Fatigue, Multiple Sclerosis, Physical Activity
Conditions
Brief summary
Multiple sclerosis (MS) is a progressive demyelinating disorder that damages white matter in the central nervous system. Although individuals experience mobility (e.g., walking, balance) impairments that lower quality of life and limit participation in daily activities, one of the most prominent symptoms is fatigue. Up to 92% of individuals report fatigue that manifests as lack of energy, exhaustion or worsening of MS symptoms and ultimately contributes to increasing disability. The currently available pharmaceutical treatments fail to fully control fatigue in the majority of individuals with MS; non-pharmacologic therapies such as exercise and behavioral therapies offer the best hope for combating MS fatigue in the majority of individuals. Exercise therapy is effective in reducing MS fatigue. However, access to exercise therapy is seriously limited for many individuals with MS due to geographical location, limited resources (e.g., financial, transportation), and/or disability. Thus, the development and evaluation of an alternative delivery method for exercise therapy to target MS-related fatigue that increases participation and reduces barriers is critical. In this study, the investigators will compare traditional in-person delivered exercise therapy to telephone-delivered exercise therapy to target fatigue in persons with MS.
Interventions
BEHAVIORALTelephone-Delivered Exercise Therapy
A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS. Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study. Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week. This home exercise program will be paired with a 1x/week telephone call with an investigator.
BEHAVIORALIn-Person Delivered Exercise Therapy
A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS. Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study. Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week. This home exercise program will be paired with a 1x/week visit to the laboratory to work with a physical therapist or trained team member.
Sponsors
National Multiple Sclerosis Society
University of Michigan
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of RRMS, SPMS, or PPMS * Ambulatory for at least 5 minutes at a time * Self-reported fatigue on Fatigue Severity Scale * Able to follow study-related commands * Able to attend study appointments
Exclusion criteria
* MS exacerbation within the past 30 days * Evidence of another neurological disorder or orthopedic disorder that would interfere with exercise participation * Acute illness or injury that prevents participation in the intervention * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Average Fatigue Intensity Score | Baseline (pre) and 8 weeks (post) | Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures. A score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue. |
| Daily Average Fatigue Interference Score | Baseline (pre) and 8 weeks (post) | Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| In-Person Delivered Exercise Participants in the in-person training group will:
1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.
2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.
In-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.
Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.
Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week. | 10 |
| Telephone-Delivered Exercise Participants in the telephone-delivered training group will:
1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.
2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.
Telephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.
Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.
Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Telephone-Delivered Exercise | In-Person Delivered Exercise | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 45.9 years STANDARD_DEVIATION 8 | 50.7 years STANDARD_DEVIATION 7.4 | 48.3 years STANDARD_DEVIATION 7.9 |
| BMI | 33.8 kg/m^2 | 29.1 kg/m^2 | 32.9 kg/m^2 |
| Fatigue Severity Scale | 47.8 units on a scale STANDARD_DEVIATION 9.5 | 51.1 units on a scale STANDARD_DEVIATION 4.1 | 48.5 units on a scale STANDARD_DEVIATION 7.3 |
| Patient Determined Disease Steps (PDDS) | 2 units on a scale | 3.5 units on a scale | 3 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
| Years Since Diagnosis | 13.5 years | 4.5 years | 8 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Daily Average Fatigue Intensity Score
Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures. A score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue.
Time frame: Baseline (pre) and 8 weeks (post)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-Person Delivered Exercise | Daily Average Fatigue Intensity Score | Pre | 3.9 units on a scale | Standard Deviation 1.9 |
| In-Person Delivered Exercise | Daily Average Fatigue Intensity Score | Post | 3.2 units on a scale | Standard Deviation 1.9 |
| Telephone-Delivered Exercise | Daily Average Fatigue Intensity Score | Pre | 4.4 units on a scale | Standard Deviation 1.1 |
| Telephone-Delivered Exercise | Daily Average Fatigue Intensity Score | Post | 2.3 units on a scale | Standard Deviation 1.5 |
Primary
Daily Average Fatigue Interference Score
Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse).
Time frame: Baseline (pre) and 8 weeks (post)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-Person Delivered Exercise | Daily Average Fatigue Interference Score | Pre | 3.1 units on a scale | Standard Deviation 1.9 |
| In-Person Delivered Exercise | Daily Average Fatigue Interference Score | Post | 2.7 units on a scale | Standard Deviation 1.8 |
| Telephone-Delivered Exercise | Daily Average Fatigue Interference Score | Pre | 3.0 units on a scale | Standard Deviation 1.3 |
| Telephone-Delivered Exercise | Daily Average Fatigue Interference Score | Post | 1.5 units on a scale | Standard Deviation 1.7 |