Title: Minimal versus specialist equipment in the delivery of pulmonary rehabilitation: a randomised controlled trial
Funder: Department of Health and Social Care

Abstract: BACKGROUND: The evidence base for pulmonary rehabilitation (PR) predominately comes from trials where the exercise component utilises specialist exercise equipment (PR-specialist). Limited data exists to support the efficacy of PR in settings that use minimal exercise equipment (PR-min). AIMS: Determine whether a PR programme using minimal exercise equipment (PR-min) is non-inferior to PR using specialist exercise equipment (PR-specialist) regarding effects on exercise capacity, quality of life, dyspnoea and quadriceps strength. DESIGN: Randomised, assessor-blind, non-inferiority trial; randomisation at individual level with 1:1 allocation, stratified according to previous completion of PR, multiple deprivation index1, and frailty status2. POPULATION: People with stable chronic respiratory disease referred for PR with MRC dyspnoea scale of two or more3. Exclusion criteria include PR in previous 12 months, and medical condition preventing safe exercise. INTERVENTION/CONTROL: PR delivered using minimal exercise equipment (PR-min) versus PR delivered using specialist exercise equipment (PR-specialist). Both interventions will comprise two supervised sessions per week for eight weeks, delivered by same PR team following the same standard operating procedures for exercise prescription and progression. DURATION and VISITS: One year duration with visits at initial assessment for PR (Visit 1), end of PR assessment (Visit 2) and 12 month follow-up (Visit 3). PRIMARY OUTCOME: Change in incremental shuttle walk distance (ISW)4 between Visits 1 and 2. SECONDARY OUTCOMES: Change in Chronic Respiratory Questionnaire (CRQ) &ndash; Dyspnoea domain5, CRQ-total5, and quadriceps strength (QMVC)6 between Visits 1 and 2. Change in ISW, CRQ-D, CRQ-total, and QMVC between Visits 1 and 3. DATA ANALYSIS: Group baseline characteristics expressed using descriptive statistics. Data analysed on intention to treat basis and per protocol. Changes in outcomes between visits 1 and 2 compared using paired t-tests or Wilcoxon signed-rank test. Proportions achieving the minimum clinically important difference (MCID) of ISW, CRQ-D, CRQ-T and QMVC compared using chi-squared test. Approach repeated for visits 1 to 3 changes in outcomes. Between-group comparisons will be compared using unpaired t-tests (95% CI) or Mann-Whitney. NON-INFERIORITY TESTING: Non-inferiority determined using the fixed-margin method with pre-stated margin (delta) of non-inferiority considered to be 50% of the established MCID of the outcome measure. Delta pre-defined as 24 metres for the ISW, 0.25 points for mean CRQ-D and CRQ-T scores and 1.25 kg for quadriceps strength. The 95% CI of between-group comparisons will be used to determine non-inferiority. HEALTH ECONOMIC ANALYSIS: EQ-5D-5L7 and a modified client service receipt inventory (CSRI) questionnaire administered at visits 1-3. Incremental cost-effectiveness ratios will be calculated, and cost-effectiveness acceptability curves plotted to summarise information on uncertainty in cost-effectiveness. A broad societal perspective will be taken, including use of all hospital and community health and social care services (public, private or voluntary sectors). PROCESS ANALYSIS: Participant recruitment/retention, PR uptake/attendance/completion, drop-out reasons, participant satisfaction. Uptake, attendance and completion rates summarised overall and compared between groups using chi-squared. SAMPLE SIZE: Previous data has shown that PR-specialist achieves mean (SD) change in ISW of 58 (67) metres. MCID of the ISW is 47.5 metres, with 24 metres the pre-defined non-inferiority margin. If no difference between PR-min and PR-specialist, then a minimum of 246 patients (123 in each group) are required to be 80% sure that the lower limit of a one-sided 97.5% CI (or equivalently a 95% two-sided CI) will be above the non-inferiority limit of -24 metres. Assuming 32% drop out from PR, the minimum sample size required for analysis will be 362 patients (181 patients per group). POTENTIAL BENEFITS TO NHS AND PATIENTS: Determine the optimal and most cost-effective way of delivering PR, a current standard of care for patients with chronic respiratory disease.

Lay abstract: Pulmonary rehabilitation is a supervised fitness programme that consists of exercise training and education designed to improve the walking ability, breathlessness, and quality of life of people with breathlessness. There is strong evidence supporting the benefits of pulmonary rehabilitation, and it is now considered routine care for people with long term lung conditions. Most of the supportive evidence comes from research where pulmonary rehabilitation was delivered in hospitals or rehabilitation centres where there was access to specialist exercise equipment, such as treadmills, exercise bikes and weights machines. However, widespread access to specialist equipment may not be feasible in many countries (including the UK), and is very limited in low-to-middle income countries. There is an increasing move towards delivering pulmonary rehabilitation classes in community sites (for example churches, or community halls) where only portable minimal equipment is available, such as hand/ankle weights, steppers, and walking courses. Some experts believe that, apart from increasing accessibility to pulmonary rehabilitation and providing locations closer to people s homes, sites providing exercise-training with minimal equipment may offer long-term benefits as these exercises are easier to maintain once patients are discharged from pulmonary rehabilitation. Other experts believe that simple equipment do not allow therapists to prescribe or progress exercise training accurately or effectively. Currently, no research has directly compared the effectiveness of pulmonary rehabilitation delivery using minimal and specialist exercise equipment. In our study, people with chronic lung disease referred to a pulmonary rehabilitation programme will be allocated by chance either to a class that uses minimal exercise equipment or a class that uses specialist exercise equipment. We will test whether minimal equipment classes are as good as those that use specialist equipment in terms of the effects on exercise capacity, breathlessness and quality of life in the short and medium term.

Research activity codes: 6.7 PHYSICAL
Health categories: RESPIRATORY