Single-blind Randomized Control Trial Research Articles

Efficacy of diclofenac transdermal patch versus injection as post-cesarean analgesia: A clinical, comparative, single-blind randomized control trial

Objectives: Post-operative pain is a common problem following cesarean delivery. The efficacy of topical application of diclofenac in alleviating pain has not been well established. We aim to evaluate the analgesic effect of transdermal diclofenac patch and compare it with the injectable form. Material and Methods: This is a prospective, randomized, single-blind, and placebo-controlled study. The study protocols and ethical considerations were adhered fully. Parturient women (n = 90) undergoing cesarean section were randomized into two equal groups: the transdermal diclofenac patch (Group A) and the injectable diclofenac (Group B). The surgery was performed under spinal anesthesia. The participant’s demographic data, clinical data, pain relief data collected, compiled, and analyzed using the Statistical Package for the Social Sciences 20. The post-operative pain was scored using Visual Analog Scale. Pain relief scores were compared between the groups using Mann–Whitney U-test and Wilcoxon matched-pair test. Results: The participants match in demographic and clinical characters. The pain relief scores at 12 h was – 3.10 ± 0.74 and 3.04 ± 0.21 respectively while at 24 hours was – 2.48 ± 0.51 and 2.09 ± 0.29 respectively in Group A and Group B. The difference between Group A and Group B was statistically significant (P = 0.0022). The pain relief scores in both groups match was statistically significant at 6–24 h and 6–48 h (P = 0.0001, 0.0001). Conclusion: Diclofenac transdermal patch gives equal pain relief as that of routine injectable formulation.

Comparison of anti-gravity treadmill training and traditional treadmill training in patients with moderate to severe knee osteoarthritis: A randomized controlled trial.

Aerobic exercise is recommended to alleviate pain and protect the joint for patients with advanced knee osteoarthritis, however, its clinical implementation is challenging due to the potential for exacerbating pain. The study aimed to compare the effects of anti-gravity treadmill training with traditional treadmill training in patients with advanced knee osteoarthritis. This single-blinded randomized-controlled trial included 30 women with knee osteoarthritis. All participants received hotpack, transcutaneous electrical nerve stimulation, and therapeutic ultrasound. Additionally, group 1 received anti-gravity treadmill, while group 2 received traditional treadmill training. Group 3 served as the control. The interventions were administered three-times a week for eight-weeks. The visual analogue scale (VAS) pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), six-minute-walk-test distance (6MWD), and femoral cartilage thickness were evaluated at baseline and weeks 4 and 8. VAS-pain significantly reduced over time in both anti-gravity (P < 0.001) and control (P = 0.004) groups. The anti-gravity group also showed significant improvements in WOMAC-pain (P = 0.008), WOMAC-total (P = 0.048), and 6MWD (P < 0.001). Post-hoc analysis indicated significant time (P < 0.001, effect size, ηp2 = 0.682) and interaction (P = 0.006, ηp2 = 0.271) effects on VAS, with no significant between-group differences. Femoral cartilage thickness showed no significant between-group differences, except within-group differences in the treadmill group (P = 0.037). Anti-gravity treadmill training significantly improved pain, functionality, and functional capacity in patients with knee osteoarthritis, while traditional treadmill resulted in a reduction in femoral cartilage thickness. Further research should investigate long-term outcomes and more diverse populations. NCT05319964.

Effect of herbal soup on immunological parameters of people living with HIV, Kenya - a parallel single blind randomized control trial

Effect of herbal soup on immunological parameters of people living with HIV, Kenya - a parallel single blind randomized control trial

263 - Warm Irrigation Improving Perioperative Outcomes of Transurethral Resection of Prostate: A Prospective Parallel Arm Single Blinded Randomized Control Trial

263 - Warm Irrigation Improving Perioperative Outcomes of Transurethral Resection of Prostate: A Prospective Parallel Arm Single Blinded Randomized Control Trial

Single-blinded, randomised, parallel-group, controlled trial comparing the efficacy and cost-effectiveness of therapist- and self-guided internet-delivered behavioural activation versus treatment as usual for adolescents with mild to moderate depression: study protocol

IntroductionThe number of adolescents seeking professional help for depression is increasing and, despite advances in treatment, large unmet treatment needs remain. In the current protocol, we describe the design and...

Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial

This study aimed to report the 5-year outcomes from the ILLUMENATE Pivotal randomized controlled trial of the lower dose (2 µg/mm2) Stellarex drug-coated balloon (DCB) (Philips, formerly Spectranetics Corp, Colorado Springs, Colorado) compared with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic peripheral arterial disease. Long-term safety and effectiveness data for DCBs remains limited. The ILLUMENATE Pivotal was a prospective, randomized, multi-center, single-blinded study. Patients (Rutherford Clinical Category 2 to 4) were randomized 2:1 to Stellarex DCB or PTA. Follow-up was through 60 months. In total, 300 patients were enrolled. The mean age was 68.8 ± 10.2 years. At 60 months, freedom from a primary safety event was 69.2% in the Stellarex DCB arm and 68.2% in the PTA arm (log-rank, p = 0.623). The cumulative rate of major adverse events was 41.0% compared with 44.6% (p = 0.597), respectively. Freedom from clinically-driven target lesion revascularization (CD-TLR) was 70.3% in the Stellarex DCB arm compared with 68.2% in the PTA arm (p = 0.505). Time to first CD-TLR was 768.3 ± 478.9 days compared with 613.5 ± 453.4 days, respectively (p = 0.161). Kaplan-Meier estimates of freedom from all-cause mortality were 80.1% in the Stellarex DCB arm and 80.2% in the PTA arm (log-rank, p = 0.980). In conclusion, the 5-year results of the ILLUMENATE Pivotal randomized controlled trial add to the consistent safety data from the broader ILLUMENATE clinical program. These are the first data to report the 5-year safety and efficacy of a lower dose (2 µg/mm2) DCB for the treatment of symptomatic peripheral arterial disease. Clinicaltrials.gov Registration:NCT01858428.

Safety and Efficacy of Oral Mifepristone for Cervical Ripening and Induction of Labor.

Background Labor induction, a common practice to prevent maternal and fetal complications from prolonged labor, involves stimulating contractions before they begin naturally. This can be achieved through medications, mechanical methods, or surgical interventions. Cervical ripening is crucial for successful delivery. When the cervix is not sufficiently ripe, drugs are often used to augment this process chemically. Objective To evaluate the safety and efficacy of mifepristone for cervical ripening and induction of labor. Method A sample size of 200 was used in this single-blind randomized control trial. Primarily, pregnant women with term pregnancies, Bishop scores <6, and cephalic fetal presentation were included in the study. The study population was randomly divided into test and control groups. The test group (n=100) was administered 200 mg of mifepristone orally, while the control group (n=100) received a placebo. The Bishop score was reassessed 24 hours after mifepristone administration. Patients were taken for labor induction if their Bishop score was >6. For individuals with a Bishop score of <6, 1 mg of dinoprostone gel was administered intracervically once every six hours. Safety and efficacy were assessed by analyzing several parameters associated with labor progression, maternal outcomes, and fetal outcomes. Results The mean age of patients in the test group was 26±4.5 years, while in the control group, it was 26±5 years. The induction-to-delivery interval was notably shorter in the test group (18.8±2.3 hours) than in the control group (19.24±1.8 hours, p<0.0001). After the administration of 200 mg mifepristone, the mean Bishop score in the test group was 5.74±0.8, compared to 5.13±0.76 in the control group. The increase in the Bishop score after mifepristone treatment was significantly higher in the test group than in the control group (p-value=0.013). In the study, 73 (73%) patients in the test group had a normal vaginal delivery (NVD), whereas NVD accounted for 64 (64%) patients in the control group. Instrumental deliveries were less frequent in the test group, accounting for 14 (14%) patients, compared to 16 (16%) patients in the control group. The frequency of lower segment cesarean section (LSCS) was also lower in the mifepristone-treated group at 13 (13%) compared to the control group at 20 (20%). Fetal distress in five (38%) patients and non-progression of labor in 11 (55%) patients were the most frequent indications for LSCS in the test and control groups, respectively. There was no significant difference in neonatal outcomes between the test and control groups. Meconium-stained liquor was the most frequent complication in both the test group(10, 10%) and the control group (5, or 5%). Conclusion Administration of mifepristone effectively increased the Bishopscores and reduced the induction-to-delivery interval compared to controls, highlighting its potential as a cervical ripening agent.

Comparison of Milrinone with Sildenafil for the Treatment of Persistent Pulmonary Hypertension of the Newborn

Objective: To compare milrinone with sildenafil for the treatment of persistent pulmonary hypertension of the newborn. Methodology: A single blinded randomized control trial was conducted in Department of Pediatrics, Aziz Fatima Hospital Faisalabad from October 2022 to September 2023. 160 infants of persistent pulmonary hypertension were included through non probablity consecutive sampling. Group 1 infants (n = 80) received a loading dose of milrinone intravenously administered over a 60-minute period at a dose of 50 µg/kg. Group 2 infants (n = 80) received sildenafil (2mg per kg per dose three times a day). The medication was continued until extubation. The primary outcome variables were the mortality and duration of hospital stay. Results: Ninety two(57.5%) of the one hubdred &amp; sixty newborns in total were male. 111(69.4%) of the total, were full-term babies. In 114(71.2%) infants, the mode of delivery was C-section. Mortality was observed in 7 (8.8%) patients in milrinone group and 17 (21.2%) patients in sildenafil group with p-value = 0.027. Duration of hospital stay was less in milrinone group as compared to sildenafil group (14.22±3.75 days vs 17.72±5.7 days) with p-value = 0.0001. Conclusion: Milrinone has been proven to be a promising therapeutic choice for persistent pulmonary hypertension in neonates, and it is effective in doing so in low resource settings.

Impact of Tai Chi and Aerobic Exercise on Cognitive Function, Balance, Cardiovascular Fitness, and Quality of Life in Older Adults: Randomized Control Trial.

Introduction Tai chi, an ancient Chinese martial art, was originally developed for combat and self-defense. Over time, it has evolved into both a sport and a form of exercise. This gentle, low-impact exercise involves performing a series of deliberate, flowing motions while focusing on deep, slow breaths. This study investigates the effects of chen tai chi and aerobic exercises on cognition, balance, cardiopulmonary fitness, and quality of life in older adults. Methodology This study employed a single-blinded randomized control trial design, enrolling 60 participants aged between 60 and 75 years. Participants were divided into three groups: Group A (aerobics), Group B (chen tai chi), and Group C (control). Exercise sessions were held four days per week over a period of four weeks. Evaluations included the Montreal Cognitive Assessment for cognition, a one-leg stand test for static balance, a Timed Up and Go Test for dynamic balance, a six-minute walk test for cardiopulmonary fitness, and a health-related quality-of-life scale. Assessments were conducted at baseline, immediately after the intervention, and at follow-up was taken after eight weeks. Results Post-intervention, improvements were observed in cognition and static balance across all groups. Within-group analysis revealed that the aerobics group experienced statistically significant enhancements in cognition (p = 0.0001) and static balance (p = 0.01). Although no statistically significant differences were found between groups in terms of dynamic balance, cardiopulmonary fitness, and quality of life, the within-group analysis showed significant improvements in the aerobics group in dynamic balance (p = 0.0009), cardiopulmonary fitness (p = 0.03), and quality of life (p = 0.0001). Conclusion Compared to chen tai chi and no intervention, the study concludes that aerobic exercise has a more pronounced effect on improving cognition, balance, cardiopulmonary fitness, and quality of life in older adults. Aerobic exercise is recommended as an effective method to prevent frailty and promote independence among the elderly.

Neurofeedback training can increase the effectiveness of neuromuscular training on balance and limit of stability of athletes with chronic ankle instability: three arms and single-blind randomized control trial

Neurofeedback training can increase the effectiveness of neuromuscular training on balance and limit of stability of athletes with chronic ankle instability: three arms and single-blind randomized control trial

Protocol for a randomised controlled trial of ketamine versus ketamine and behavioural activation therapy for adults with treatment-resistant depression in the community

IntroductionAlthough short-term benefits follow parenteral ketamine for treatment-resistant major depressive disorder (TR-MDD), there are challenges that prevent routine use of ketamine by clinicians. These include acute dissociative effects of parenteral...

EFFECT OF ADDITION OF DEXAMETHASONE TO ROPIVACAINE ON POST-OPERATIVE ANALGESIA IN ULTRASOUND-GUIDED TRANSVERSE ABDOMINIS PLANE BLOCK FOR ANTERIOR ABDOMINAL WALL HERNIA REPAIR

Objective: The objective of the present study was to evaluate the adjuvant effect of dexamethasone to Ropivacaine in ultrasound-guided transverse abdominal plan block for anterior abdominal wall hernia repair. Methods: A single-blind randomized control trial was conducted by selecting patients undergoing anterior abdominal wall hernia and dividing them into two groups with Group A: received a total of 50 mL of 0.2% Ropivacaine (48 mL) with normal saline (2 mL) and Group B received a total 50 mL of 0.2% Ropivacaine (48 mL) with 8 mg dexamethasone (2 mL). Outcome was assessed on the basis of visual analog scale (VAS), the requirement of rescue analgesia, and adverse events. Results: Twenty-seven patients were recruited in each group, Group A and Group B had an average pain-free interval of 11.85±2.82 and 8.07±2.51, respectively (p&lt;0.001). Mean VAS was lower in Group B at the end of 2 h (p&lt;0.05). Both the groups had similar side effects with no significant difference. Total analgesia dose required in Groups B and A was 75 and 96 mg, respectively (p&lt;0.001). Conclusion: A combination of 0.2% Ropivacaine (48 mL) with 8 mg dexamethasone (2 mL) significantly reduces the VAS in post-operative pain along with reduced quantity and frequency of rescue analgesia.

Randomized controlled trial of the CMR immersive virtual reality (IVR) headset training compared to e-learning for operating room configuration of the CMR versius robot

Robotic surgery offers potential advantages over laparoscopic procedures, but the training for configuring robotic systems in the operating room remains underexplored. This study seeks to validate immersive virtual reality (IVR) headset training for setting up the CMR Versius in the operating room. This single-blinded randomized control trial randomised medical students with no prior robotic experience using an online randomiser. The intervention group received IVR headset training, and the control group, e-learning modules. Assessors were blinded to participant group. Primary endpoint was overall score (OS): Likert-scale 1–5: 1 reflecting independent performance, with increasing verbal prompts to a maximum score of 5, requiring physical assistance to complete the task. Secondary endpoints included task scores, time, inter-rater reliability, and concordance with participant confidence scores. Statistical analysis was performed using IBM SPSS Version 27. Of 23 participants analysed, 11 received IVR and 12 received e-learning. The median OS was lower in the IVR group than the e-learning group 53.5 vs 84.5 (p < 0.001). VR recipients performed tasks independently more frequently and required less physical assistance than e-learning participants (p < 0.001). There was no significant difference in time to completion (p = 0.880). Self-assessed confidence scores and assessor scores differed for e-learning participants (p = 0.008), though not IVR participants (p = 0.607). IVR learning is more effective than e-learning for preparing robot-naïve individuals in operating room set-up of the CMR Versius. It offers a feasible, realistic, and accessible option in resource-limited settings and changing dynamics of operating theatre teams. Ongoing deliberate practice, however, is still necessary for achieving optimal performance. ISCRTN Number 10064213.

Efficacy of Early Intervention for Infants With Cerebral Palsy in an LMIC: An RCT.

To test efficacy of a parent-delivered multidomain early intervention (Learning through Everyday Activities with Parents [LEAP-CP]) for infants with cerebral palsy (CP) compared with equal-dose of health advice (HA), on (1) infant development; and (2) caregiver mental health. It was hypothesized that infants receiving LEAP-CP would have better motor function, and caregivers better mental health. This was a multisite single-blind randomized control trial of infants aged 12 to 40 weeks corrected age (CA) at risk for CP (General Movements or Hammersmith Infant Neurologic Examination). Both LEAP-CP and HA groups received 15 fortnightly home-visits by a peer trainer. LEAP-CP is a multidomain active goal-directed intervention. HA is based on Key Family Practices, World Health Organization. Primary outcomes: (1) infants at 18 months CA: Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT mobility); and (2) caregiver: Depression Anxiety and Stress Scale. Of eligible infants, 153 of 165 (92.7%) were recruited (86 males, mean age 7.1±2.7 months CA, Gross Motor Function Classification System at 18 m CA: I = 12, II = 25, III = 9, IV = 18, V = 32). Final data were available for 118 (77.1%). Primary (PEDI-CAT mobility mean difference = 0.8 (95% CI -1.9 to 3.6) P = .54) and secondary outcomes were similar between-groups. Modified-Intention-To-Treat analysis on n = 96 infants with confirmed CP showed Gross Motor Function Classification System I and IIs allocated to LEAP-CP had significantly better scores on PEDI-CAT mobility domain (mean difference 4.0 (95% CI = 1.4 to 6.5), P = .003) compared with HA. Although there was no overall effect of LEAP-CP compared with dose-matched HA, LEAP-CP lead to superior improvements in motor skills in ambulant children with CP, consistent with what is known about targeted goal-directed training.

Comparison of Nonimmersive Virtual Reality and Task-Oriented Circuit Training on Gait, Balance, and Cognition Among Elderly Population: A Single-Blind Randomized Control Trial.

Purpose: The purpose of this study was to determine the effects of nonimmersive virtual reality (VR) and task-oriented circuit training on gait, balance, cognitive domains, and quality of life among the elderly population. Methods: This is a single-blind randomized control trial in which 28 elderly individuals between 60 and 75 years were selected. The participants were divided into two groups, task-oriented circuit training and the other receiving nonimmersive VR treatment, with 14 participants in each group. To analyze the effects of both training on balance and gait time up and go test (TUGT), dynamic gait index (DGI), measures were used and for cognitive domains Montreal cognitive assessment (MoCA) scale was used. Short form 12 (SF-12) (along with two domains, Physical Component Summary and Mental Component Summary) was used for the measurement of quality of life. The treatment duration was 8 weeks for both groups. Both the pre-test and post-test readings were analyzed and compared. Results: The mean age of participants was 66.91 ± 3.79 years. Within-group comparison between the pre-test and post-test indicated that significant differences (P < 0.05) existed in all the outcome measures (TUGT, DGI, MoCA, and SF-12) in both groups. However, between-group comparison, significant differences were only found in TUGT and DGI in nonimmersive VR group. Conclusion: This study concluded that both interventions nonimmersive VR and task-oriented circuit training were beneficial for improving balance, gait, quality of life, and cognitive domains like memory, attention spans, executive functions, and so on in elderly population. However nonimmersive virtual reality training is a more effective, feasible, and safe alternative and can be proposed as a form of fall prevention exercise for the older adults. ClinicalTrials.gov Identifier: NCT05021432.

Atracurium for Rapid Sequence Induction; A dose determining Randomized Control Trial at a Tertiary Care Hospital.

Introduction: Expert airway management is one of the essential anesthetic skills. Rapid Sequence induction is a technique of providing rapid securement of airway with endotracheal tube in patients who are at risk of aspiration. Objective: To find out the efficacy of 3-4 ED95 dose of Atracurium in providing optimal intubating conditions for Rapid Sequence Induction. Methodology: Single-blind randomized control trial was carried out Department of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences (PIMS), Islamabad. 118 patients were included and divided into two groups by help of computer-generated random numbers. All the patients were pre-medicated with 8 mg of IV Dexamethasone. Group A patients received 1 mg/kg while group B patients received 0.75 mg/kg of Atracurium. Intubating conditions were assessed on the basis of number of coughing episodes along with degree of vocal cord movement or paralysis. Results: Patients who received 0.75 mg/kg of Atracurium had statistically significant better intubating conditions as compared to those receiving 1 mg/kg of Atracurium (p value &lt; 0.05). Coughing episodes were more common among patients receiving higher dose of Atracurium while degree of vocal cord paralysis was similar in both groups. Furthermore 75% of histamine related adverse effects such as erythema and bronchospasm were observed in higher dose group. The difference was statistically significant with a p value of &lt;0.05. Conclusion: Atracurium at a dose of 0.75 mg/kg along with pre-medication with 8 mg of IV Dexamethasone provided better and safer intubating conditions for rapid sequence induction.

The Influence of Honey and Hydrogel Products Therapy on Healing Time in Diabetic Foot.

Diabetic foot ulcer is a serious and common complication of diabetes that often leads to significant morbidity and even amputation if not properly treated. Current treatment options, such as wound dressing, have limitations in promoting efficient healing. There is a need for effective interventions that can expedite the healing process and enhance the time required for complete healing. This prospective single-blinded randomized control trial studied diabetic mellitus type 2 patients with ulcer in their second-degree feet from February 2019 to February 2023 in the Diabetic Foot Center, King Fahad Specialist Hospital Al Qassim-KSA. This study involved 120 patients with a mean age of 59.64 ± 10.21. And 63% to 52.5% of them were males and 57% to 47.5% were females. The mean healing time was about 12.76 ± 4.08 days. Cases were divided into 4 equal groups with altered treatment procedures: honey alone, hydrogel alone, honey, and hydrogel combination alternately (3 intervention groups), and fucidin ointment or cream alone (1 control group), with 30 participants in each group. We revealed that the mean healing times for honey alone, hydrogel alone, and honey and hydrogel alternately were 12.20, 13.97, and 10.83 days, respectively. While it was 14.03 days in the control Fucidin ointment or cream [significantly P < .05 (P = .004)]. From the findings of the present study, we noticed that faster healing time among diabetic foot cases could be accomplished by treatment with a combination of honey and hydrogel alternately. Therefore, this therapy is effective in reducing the risk of diabetic foot ulcers.

The Effectiveness of Photobiomodulation Using 940-nm Diode Laser for Reducing Pain, Swelling and Trismus After Third Molar Surgery: A Single-Blinded Randomized Control Trial

The Effectiveness of Photobiomodulation Using 940-nm Diode Laser for Reducing Pain, Swelling and Trismus After Third Molar Surgery: A Single-Blinded Randomized Control Trial

Effects of Decompression therapy in leg pain and straight leg rise in patient with lumbar radiculopathy due to disc protrusion

One among many disc problems is disc protrusion, which has more prevalence in outpatient department physical therapy management Centre globally. The purpose of this study was to compare the effect of lumbar spine decompression therapy and standard physical therapy treatment in patients with lumbar radiculopathy due to disc protrusion. The single-blind randomized control trial of 71 patients was conducted at Max Rehab &amp; Physical Therapy Centre Islamabad, Pakistan. After setting inclusion criteria all the patients were randomly allocated into treatment and control group. Both group received standard physical therapy treatment including, Moist Hot pack, Lumbar Mobilization, Stretching &amp; strengthening exercises. The only difference was that Decompression Group received additional Decompression therapy. The data included demographics and Numeric Pain Rating Scale score in supine lying position for the painful leg and Straight Leg Raise Range for the painful side. The values for leg pain for control group decreased from 6 to 3 and the value for straight leg raise increased from 15° to 49°. The values for leg pain for the Decompression Group decreased from 6 to 2 and the value for the straight leg raise increased from 10° to 48°, the p value for both the variables was &lt;.001 showing statistically significant difference between pre and post values in treating patients leg pain and straight leg raise range of motion. It is concluded that decompression therapy is more effective in managing lumbar radiculopathy.

Exercise and brain health in patients with coronary artery disease: study protocol for the HEART-BRAIN randomized controlled trial.

Patients with coronary artery disease (CAD) have a higher risk of developing cognitive impairment and mental health disorders compared to the general population. Physical exercise might improve their brain health. The overall goal of the HEART-BRAIN randomized controlled trial (RCT) is to investigate the effects of different types of exercise on brain health outcomes in patients with CAD, and the underlying mechanisms. This three-arm, single-blinded RCT will include 90 patients with CAD (50-75 years). Participants will be randomized into: (1) control group-usual care (n = 30), (2) aerobic high-intensity interval training (HIIT) (n = 30), or (3) HIIT combined with resistance exercise training (n = 30). The 12-week intervention includes 3 supervised sessions (45-min each) per week for the exercise groups. Outcomes will be assessed at baseline and post-intervention. The primary outcome is to determine changes in cerebral blood flow assessed by magnetic resonance imaging. Secondary outcomes include changes in brain vascularization, cognitive measures (i.e., general cognition, executive function and episodic memory), and cardiorespiratory fitness. Additional health-related outcomes, and several potential mediators and moderators will be investigated (i.e., brain structure and function, cardiovascular and brain-based biomarkers, hemodynamics, physical function, body composition, mental health, and lifestyle behavior). The HEART-BRAIN RCT will provide novel insights on how exercise can impact brain health in patients with CAD and the potential mechanisms explaining the heart-brain connection, such as changes in cerebral blood flow. The results may have important clinical implications by increasing the evidence on the effectiveness of exercise-based strategies to delay cognitive decline in this high-risk population. ClinicalTrials.gov, identifier [NCT06214624].