Abstract
BackgroundThere is inconclusive evidence for the effectiveness of additional exercise in older hospital patients. The aims of this study were (1) to assess the feasibility of an augmented prescribed exercise program (APEP) in older acute medical patients and (2) to measure the potential effects of APEP on mobility capacity in order to assess the feasibility of a large full-scale study.MethodsWe conducted a single-center, prospective, parallel-group, single-blinded, randomized (1:1) controlled pilot and feasibility trial. Participants were recruited from acute geriatric wards of a general hospital. Key inclusion criteria were: age ≥ 65 years and walking ability. Key exclusion criteria were severe cognitive impairment and medical restriction for physical exercise interventions.Both groups received usual care, including physiotherapy. Intervention group participants were scheduled for additional exercise sessions (20–30 min, 4-5x/week). Feasibility of the trial design was assessed along pre-defined criteria for process, resources and management. Feasibility of the APEP intervention was analyzed by means of adherence, compliance and safety. Outcomes were measured at baseline and prior to hospital discharge. The primary outcome was mobility capacity (de Morton Mobility Index; DEMMI). Secondary outcomes were walking ability, physical endurance, fear of falling, frailty and length of stay.ResultsThirty-five participants were recruited (recruitment rate 20.3%). We lost 7 participants to follow-up (retention rate: 80%). Intervention group participants (n = 17) each participated in 5.3 ± 2.2 additional exercise sessions (mean duration: 23.2 ± 4.0 min; mean adherence rate 78% ± 26%). No severe adverse events occurred during study assessments or APEP sessions.There were no statistically significant differences in mean change scores in any outcome measure. A sample of 124 participants would be required to detect a difference of 4 DEMMI points (ES = 0.45) with a power of 80%.ConclusionsThis small feasibility RCT indicates that an APEP intervention may be safe and feasible in older acute medical patients. APEP may possibly induce small to moderate effects on mobility, but the clinical relevance of these effects may be limited. These results inform the planning of a larger-scale phase III study.Trial registrationGerman Clinical Trials Register (DRKS00011262). Registered 27 October 2016.
Highlights
There is inconclusive evidence for the effectiveness of additional exercise in older hospital patients
No further augmented prescribed exercise program (APEP) sessions were scheduled for this participant, who withdrew from the trial and who missed the follow-up assessment due to immediate discharge within 2 weeks after hospital admission
To reach the sample size of 124 participants, the main study might be performed as a multi-centre study to address recruitment issues observed in a single hospital. This pilot randomized controlled trial (RCT) provides evidence that the proposed study protocol for a phase III trial to determine the effectiveness of an APEP intervention in acute geriatric care is feasible
Summary
There is inconclusive evidence for the effectiveness of additional exercise in older hospital patients. Many older hospital patients have a significantly reduced mobility capacity and show low levels of physical activity. Most participants had functional limitations with mobility activities at admission and discharge, such as changing basic body position (68 and 39%, respectively) or walking (79 and 61%, respectively). These mobility limitations can lead to a reduced physical functioning and physical activity. Brown et al [7] reported that geriatric inpatients spend on average 20 h in bed, 3 h in a sitting position and only 43 min per day standing or walking. Physical activity levels are low when therapy was not available: in the late afternoon, during the evenings and on weekends [13]
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