Efficacy of a physical activity programme combining individualized aerobic exercise and coaching to improve physical fitness in neuromuscular diseases (I’M FINE): study protocol of a randomized controlled trial

Abstract

Background: In individuals with neuromuscular diseases (NMD), symptoms of muscle weakness, fatigue and pain may limit physical activity. Inactivity leads to reduced physical fitness, which further complicates daily life functioning. Due to inconclusive evidence regarding exercise in NMD, the optimal training approach and strategies to preserve an active lifestyle remain to be determined. The physical activity programme I'M FINE, consisting of individualized aerobic exercise to improve physical fitness and coaching to preserve an active lifestyle, was therefore developed. The primary objective of this study will be to evaluate the efficacy of the I'M FINE programme in terms of improved physical fitness in individuals with slowly progressive NMD, compared to usual care. Methods: A multicentre, assessor-blinded, two armed, randomized controlled trial will be conducted in a sample of 90 individuals with slowly progressive NMD. Participants motivated to improve their reduced physical fitness will be randomized (ratio 1:1) to the I'M FINE intervention or usual care. The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle. Measurements will be performed at baseline, post-intervention, and at 12-and 18-months follow-up. The primary outcome is peak oxygen uptake (VO 2 peak) directly post intervention. Main secondary outcomes are physical capacity, muscle strength, self-efficacy, daily activity, quality of life and markers of metabolic syndrome. The primary analysis compares change in VO 2 peak post-intervention between the intervention and usual care group, with analysis of covariance. Discussion: The I'M FINE study will provide evidence regarding the efficacy of a physical activity intervention on the physical fitness and active lifestyle over the short-and long-term in individuals with slowly progressive NMD. These outcomes could potentially improve the (inter)national guidelines for efficacy of aerobic exercise programmes and provide insight in achieving a more active lifestyle in NMD.

Relationship Between Heart Rate and Perceived Exertion in Neuromuscular Diseases: How do Laboratory-Based Exercise Testing Results Translate to Home-Based Aerobic Training Sessions?

“…The study used data collected as part of an ongoing randomized controlled trial, called I'M FINE, on the efficacy of a physical activity programme combining individualized aerobic training and coaching to improve physical fitness in NMD (https://trialsearch.who. int/Trial2.aspx?TrialID = NTR7609) (14). Participants were randomized to a physical activity programme or usual care.…”

“…Exclusion criteria were: contraindications for physical activity according to the American College of Sports Medicine (ACSM) guidelines; unable to follow verbal or written Dutch instructions; engagement in a training programme for a period longer than 4 weeks during the past 6 months. A more detailed description can be found in the published study protocol (14).…”

“…Aerobic training was guided by HR and consisted of a 4-month polarized, home-based programme, with 2 low-intensity sessions and 1 high-intensity session per week (see www.amc.nl/trainingguide and previous publications for more details, including the rationale) (14,17). Training sessions included exercise intervals, interspersed with recovery periods.…”

Ageing with neuromuscular disease: Implications for a lifeworld‐led care through a humanising approach

“…In slowly progressing subtypes, symptoms like fatigue, poor endurance and pain make it increasingly difficult to engage in physical activity. This in turn leads to a more sedentary lifestyle, which may affect general health and daily functioning (Oorschot et al, 2020). However, no differences in quality of life between diagnosis‐based NMD subgroups have been found (Bos et al, 2019).…”

Chronic inflammatory neuropathies and their impact on activities and participation

“…Despite this lack of our understanding of involved mechanisms, rehabilitation strategies may also address and help to ameliorate their impact. Exercise programs in NMD have been shown to have promising results in reducing fatigue, especially individualized programs, and could also be effective in CIDP and MMN patients, in addition to abolishing known contributing factors to fatigue[10,[38][39][40].…”