Abstract
BackgroundChronic fatigue is present in more than 60% of the patients with a neuromuscular disease and can be their most disabling symptom. In combination with other impairments, fatigue often results in low levels of physical activity and decreased social participation, leading to high societal costs. ‘Energetic’ is a self-management group program aimed at improving social participation, physical endurance and alleviating fatigue in these patients. The primary aim of this study is to evaluate the effectiveness and cost-effectiveness of the Energetic program.Methods/DesignA multicentered, assessor-blinded, two-armed randomized controlled trial is conducted with evaluations at inclusion and four, seven and fifteen months later. The study includes patients with a neuromuscular disease and chronic fatigue and, when present, their caregivers. The participants are randomized (ratio 1:1) to either an intervention group, receiving the Energetic program, or a control group, receiving usual care (i.e., no specific intervention). The Energetic program covers four months and includes four modules: 1) individually tailored aerobic exercise training; 2) education about aerobic exercise; 3) self-management training in applying energy conservation strategies; and 4) implementation and relapse prevention in daily life. Two months after cessation of the program a booster session is provided. The primary outcome is the perceived performance score of the Canadian Occupational Performance Measure (COPM). Secondary outcomes include the COPM-satisfaction score, and measures of fatigue, physical endurance, activity engagement, mood, and self-efficacy. Caregiver burden is also evaluated as a secondary outcome. Health-related quality of life and medical and societal costs are assessed to estimate cost-effectiveness of the program.DiscussionThe Energetic study is the first randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical and self-management group training program for improving social participation, physical endurance and alleviating fatigue in patients with neuromuscular diseases. It will generate new insights in (cost-)effective rehabilitation strategies for these incurable conditions.Trial registrationClinicaltrials.gov NCT02208687.
Highlights
Chronic fatigue is present in more than 60% of the patients with a neuromuscular disease and can be their most disabling symptom
In combination with muscle weakness, enhanced fall risk, and possible cardiopulmonary involvement, fatigue often results in low levels of physical activity and decreased social participation, which in turn leads to high societal costs
Both interventions were based on a theoretical model of chronic fatigue in neuromuscular disease (NMD), in which muscle strength, level of self-reported physical activity, sleep disturbances and pain were all associated with fatigue and, with social participation [7]
Summary
To the best of our knowledge, the Energetic study is the first randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical and self-management group training program for improving social participation, physical endurance and alleviating fatigue in patients with neuromuscular diseases (NMDs). The current study includes patients with various forms of NMD, but focuses on patients with FSHD, IBM and MM These are all chronic degenerative muscle diseases with a slowly progressive character. We purposively included three clinical settings for a first implementation of the Energetic program: besides a university medical center, we selected a regional rehabilitation center and a community health center. This choice allows us to evaluate barriers and facilitators of implementation in each of these settings, which will help future dissemination of the Energetic program across other health institutions.
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