Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis.

BACKGROUND: Successful translation of evidence-based exercise training interventions from research to clinical practice depends on the balance of treatment fidelity and adaptability when delivering the exercise program across settings. The current paper summarizes fidelity of study design, provider training, and intervention delivery strategies from best practice recommendations, and reports challenges experienced and adaptations instrumented by behavioral coaches delivering the multi-site Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis (STEP for MS) Trial. METHODS: Using a reflexive thematic analysis approach, open-ended survey questions were analyzed to explore experiences of behavioral coaches, transcripts from team meetings among behavioral coaches, and notes from audits of one-on-one sessions between behavioral coaches and participants. RESULTS: Themes related to the fidelity of study design and delivery of the STEP for MS Trial included adaptations to the intervention itself (e.g., completion of virtual supervised exercise sessions with behavioral coaches in place of face-to-face sessions during COVID-19 pandemic restrictions), modification of exercise equipment, and adjustments of program delivery. The adjustments of program delivery reported by behavioral coaches included increasing program fit, maintaining engagement, and addressing participant safety concerns; however, these adaptations did not jeopardize the content of the essential elements of the program model. CONCLUSIONS: The current paper demonstrates that when best practice recommendations are implemented, it is possible to address challenges to study design and evidence-based intervention delivery in ways that adaptations to overcome real-world obstacles can be accomplished without compromising fidelity.

Effects of Functional Electrical Stimulation Cycling on Fatigue and Quality of Life in People with Multiple Sclerosis Who Are Nonambulatory.

BACKGROUND: Functional electrical stimulation (FES) cycling provides an exercise opportunity for people with multiple sclerosis (MS) who are nonambulatory. This study evaluated the efficacy of FES cycling for reducing fatigue and improving quality of life in people with MS who are nonambulatory and compared outcomes with those in a control group that did not take part in FES cycling. METHODS: Adults with MS with self-reported Expanded Disability Status Scale scores of 7.0 to 8.5 were randomized into a training group (n = 12) or a control group (n = 9). The training group performed FES cycling for 30 minutes, two to three times a week for 12 weeks. The primary outcome was safety, measured as the number and type of adverse events and any increase in symptoms. Other outcomes collected before and after the intervention were scores on the modified Ashworth Scale, manual muscle test, 5-item Modified Fatigue Impact Scale (MFIS-5), Fatigue Scale for Motor and Cognitive Functions (FSMC), Medical Outcomes Study Pain Effects Scale, Patient Health Questionnaire-9 (PHQ-9), Multiple Sclerosis Quality of Life-54 (MSQOL-54), and Exercise Self-Efficacy Scale. RESULTS: Twelve participants completed the study and were analyzed. Six participants completed training with no adverse events. The MFIS-5 (Cohen's d = 0.60), FSMC (Cohen's d = 0.37), and PHQ-9 (Cohen's d = 0.67) scores and the physical health composite of the MSQOL-54 (Cohen's d = 1.48) improved for the training group compared with the control group (n = 6). CONCLUSIONS: Functional electrical stimulation cycling is safe for people with MS who are nonambulatory and may reduce fatigue and improve measurements of quality of life.

Safety and Feasibility of Various Functional Electrical Stimulation Cycling Protocols in Individuals With Multiple Sclerosis Who Are Nonambulatory.

OBJECTIVE: To examine the safety, feasibility, and response to functional electrical stimulation (FES) cycling protocols requiring differing levels of effort in people with multiple sclerosis (MS) who are nonambulatory. DESIGN: Pilot study with pre-post intervention testing. SETTING: Outpatient clinic setting of a long-term acute care hospital. PARTICIPANTS: Individuals (N=10) with MS (6 men; mean age 58.6±9.86y) who use a wheelchair for community mobility. Participants' Expanded Disability Status Scale score ranged from 6.5 to 8.5 (median 7.5). INTERVENTION: Participants performed 3 or 4 FES cycling protocols requiring different levels of volitional effort during 6-8 testing sessions. MAIN OUTCOME MEASURES: The primary outcome was safety, measured by adverse events and increase in MS symptoms, all assessed throughout, immediately post- and 1 day postsession. FES cycling performance for each protocol was also recorded. Exploratory outcome measures collected before and after all testing sessions included functional assessment of MS, MS Impact Scale, Exercise Self Efficacy Scale, Patient Health Questionnaire-9 item, and the Zarit Caregiver Burden Scale. RESULTS: All participants (4 women, 6 men) completed all testing sessions. There were no serious adverse events or differences in vitals or symptoms between protocols. Two participants had an isolated episode of mild hypotension. Changes in pain, spasticity, and fatigue were minimal. Five participants were able to cycle for 30 minutes and completed interval training protocols requiring increasing difficulty. The remainder cycled for <3 minutes and completed a rest interval protocol. There was modest improvement on the exploratory outcome measures. CONCLUSIONS: People with MS who use a wheelchair for community mobility can safely perform FES cycling requiring more effort than previously reported research. Therefore, the individuals may experience greater benefits than previously reported. Further study is required to better understand the potential benefits for optimizing function and improving health in people with MS.

Effects of Treadmill Training on Muscle Oxidative Capacity and Endurance in People with Multiple Sclerosis with Significant Walking Limitations.

BACKGROUND: Exercise can improve muscle function and mobility in people with multiple sclerosis (MS). However, the effects of exercise training on skeletal muscle oxidative capacity and endurance in people with MS remain unclear, and few studies have evaluated muscle plasticity in people with MS who have moderate-to-severe disability. The present study evaluated the effects of treadmill training on muscle oxidative capacity and muscle endurance and examined the relationship to walking function in people with MS who have moderate-to-severe disability. METHODS: Six adults (mean ± SD age, 50 ± 4.9 years) with MS (Expanded Disability Status Scale score, 6.0-6.5) performed treadmill training for 24 minutes approximately twice per week for approximately 8 weeks (16 sessions total) using an antigravity treadmill system. The following measures were taken before and after the intervention phase: muscle oxidative capacity in the medial gastrocnemius using near-infrared spectroscopy after 15 to 20 seconds of electrical stimulation; muscle endurance in the medial gastrocnemius using accelerometer-based mechanomyography during 9 minutes of twitch electrical stimulation in three stages (3 minutes per stage) of increasing frequency (2, 4, and 6 Hz); and walking function using the 2-Minute Walk Test. RESULTS: Mean ± SD muscle oxidative capacity increased from 0.64 ± 0.19 min-1 to 1.08 ± 0.52 min-1 (68.2%). Mean ± SD muscle endurance increased from 80.9% ± 15.2% to 91.5% ± 4.8% at 2 Hz, from 56.3% ± 20.1% to 76.6% ± 15.8% at 4 Hz, and from 29.2% ± 13.1% to 53.9% ± 19.4% at 6 Hz of stimulation in the gastrocnemius. There were no significant improvements in walking function. CONCLUSIONS: Treadmill training can improve muscle oxidative capacity and endurance in people with MS who have moderate-to-severe levels of disability.

Case Report: Effect of Antigravity Treadmill Training on Muscle Oxidative Capacity, Muscle Endurance, and Walking Function in a Person with Multiple Sclerosis.

BACKGROUND: Exercise training can improve skeletal muscle metabolism in persons with multiple sclerosis (MS). However, quantification of exercise-mediated improvements in muscle metabolism has been limited, particularly in people with high levels of disability. We evaluated the effect of 9 weeks of antigravity treadmill training on muscle oxidative capacity and muscle endurance and assessed the relationship to walking function in a person with MS. METHODS: One person with MS (Expanded Disability Status Scale score, 6.5) performed treadmill training for 24 minutes approximately twice weekly for 9 weeks (16 sessions) using an antigravity treadmill system. Before and after the intervention phase, we measured muscle oxidative capacity in the medial gastrocnemius using near-infrared spectroscopy after 15 to 20 seconds of electrical stimulation; muscle endurance in the medial gastrocnemius using accelerometer-based mechanomyography during 9 minutes of twitch electrical stimulation in three stages (3 minutes per stage) of increasing frequency (2, 4, and 6 Hz); muscle strength (plantarflexion) using a maximal voluntary contraction; and walking function using the Timed 25-Foot Walk test and the 2-Minute Walk Test. RESULTS: Muscle oxidative capacity increased from 0.73 min-1 to 1.08 min-1 (48%). Muscle endurance increased from 75.9% to 84.0% at 2 Hz, from 67.8% to 76.2% at 4 Hz, and from 13.5% to 44.7% at 6 Hz. Maximal voluntary contraction decreased by 0.68 kg (15%), Timed 25-Foot Walk test speed decreased by 0.19 ft/s (20%), and 2-Minute Walk Test distance increased by 65 m (212%). CONCLUSIONS: Muscle oxidative capacity and muscle endurance, as well as walking function, improved in a person with MS after training on an antigravity treadmill.

Skeletal muscle mitochondrial capacity in people with multiple sclerosis.

BACKGROUND: People with multiple sclerosis (MS) have functional disability and may have reduced muscle mitochondrial capacity. OBJECTIVE: The objective of this paper is to measure muscle mitochondrial capacity of leg muscles using near-infrared spectroscopy (NIRS) and compare to functional status. MATERIALS AND METHODS: People with MS (n = 16) and a control (CON) group (n = 9) were evaluated for 25-ft walk time. Mitochondrial capacity of both gastrocnemius muscles were measured with NIRS as the rate of recovery of oxygen consumption in after exercise. RESULTS: Mitochondrial capacity was lower in the MS group compared to the CON group (rate constants: 1.13 ± 0.29 vs. 1.68 ± 0.37 min-1, p < 0.05). There was a tendency for people with MS who used assistive devices to have lower mitochondrial capacity in the weaker leg (p = 0.07). CONCLUSION: NIRS measurements of mitochondrial capacity suggest a 40% deficit in people with MS compared to CONs and this may contribute to walking disability.