Abstract
BackgroundExercise training is an important component of pulmonary rehabilitation (PR) programmes in chronic obstructive pulmonary disease (COPD), but the great majority of COPD patients who would benefit from PR never follow such programmes or fail to maintain exercise training after PR completion. Against this background, we developed an exercise training programme that requires minimal equipment and can be implemented long-term in the patient’s home-setting. The aims of the HOMEX-1 and HOMEX-2 trials are to assess the effectiveness of this home-based exercise training programme in two groups of COPD patients over the course of one year: patients who have completed PR (HOMEX-1 trial) and patients who did not enrol in existing PR programmes within the last two years (HOMEX-2 trial).MethodsHOMEX-1 and HOMEX-2 are multicentre, parallel group, randomised controlled trials. For both trials each, it is planned to include 120 study participants with a diagnosis of COPD. Participants will be randomised with a 1:1 ratio into the intervention group or the control group (usual care/no intervention). The intervention consists of minimal-equipment exercise training elements with progressive level of intensity, conducted by the participant during six days per week and instructed and coached by a trained health care professional during three home visits and regular telephone calls during one year. Primary outcome is change in dyspnoea (domain of Chronic Respiratory Questionnaire) from baseline to 12-months follow-up. Secondary outcomes are change in dyspnoea over the course of the year (assessed at 3, 6 and 12 month) and change in functional exercise capacity, physical activity, health-related quality of life, health status, exacerbations and symptoms from baseline to 12 months follow-up. In addition, explanatory, safety and cost-effectiveness outcomes will be assessed. We will conduct intention-to-treat analyses separately per trial and per protocol analyses as sensitivity analyses.DiscussionThe HOMEX-1 and HOMEX-2 trials assess a novel intervention that provides an innovative way of making exercise training as accessible as possible for COPD patients. If the intervention proves to be effective long-term, it will fill the gap of providing an easily accessible and feasible intervention so that more COPD patients can follow an exercise programme.Trial registrationClinicalTrials.gov Identifier: HOMEX-1 NCT03461887 (registration date: March 12, 2018; retrospectively registered); HOMEX-2 NCT03654092 (registration date: August 31, 2018).
Highlights
Exercise training is an important component of pulmonary rehabilitation (PR) programmes in chronic obstructive pulmonary disease (COPD), but the great majority of COPD patients who would benefit from PR never follow such programmes or fail to maintain exercise training after PR completion
Of the studies that focused on home-based training alone, the programmes typically lasted eight to twelve weeks, the follow-up assessments were primarily conducted at the end of the programme without a more long-term perspective and their effect on health-related quality of life (HRQoL) and exercise tolerance compared to usual care was not consistent across studies [8,9,10,11,12,13,14,15,16,17]
At T3, study staff will call the participants to verify in detail the questions regarding cost-effectiveness and other exercise training 2) Randomisation will be conducted at the end of visit T1, after all assessments have been conducted 3) HOMEX-1 participants: measurements are already collected during rehabilitation; HOMEX-2 participants: a lung function measurement will be conducted by a handheld spirometer 4) HOMEX-2 only intervention will be assessed by a satisfaction questionnaire and a brief semi-structured interview and/or focus groups at 12-months follow-up
Summary
Study design HOMEX-1 and HOMEX-2 are multicentre, randomised (ratio 1:1), parallel group, controlled trials (Clinical trials.gov Identifier: NCT03461887 and NCT03654092). At T3, study staff will call the participants to verify in detail the questions regarding cost-effectiveness and other exercise training 2) Randomisation will be conducted at the end of visit T1, after all assessments have been conducted 3) HOMEX-1 participants: measurements are already collected during rehabilitation; HOMEX-2 participants: a lung function measurement will be conducted by a handheld spirometer 4) HOMEX-2 only intervention will be assessed by a satisfaction questionnaire and a brief semi-structured interview (participants) and/or focus groups (with participants and health professionals separately) at 12-months follow-up. EBPI study staff will conduct three monitoring visits at each study centre; one 4 to 8 weeks after the conduction of the first baseline visit, a second after completion of all baseline assessments and a third after completion of all 12-months follow-up assessments During these visits, the monitor will participate in one visit and verify whether the participants’ instruction, data assessment and randomisation are conducted according to protocol and check whether study procedures, documentation and REDCap data entry are conducted correctly.
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