Trial Outcomes & Findings for Telephone-Delivered Exercise for Multiple Sclerosis Fatigue (NCT NCT03256851)

Last Updated: 2019-10-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline (pre) and 8 weeks (post)

Results posted on

2019-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	In-Person Delivered Exercise n=10 Participants 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.	Telephone-Delivered Exercise n=10 Participants 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.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Continuous	50.7 years STANDARD_DEVIATION 7.4 • n=10 Participants	45.9 years STANDARD_DEVIATION 8.0 • n=10 Participants	48.3 years STANDARD_DEVIATION 7.9 • n=20 Participants
Sex: Female, Male Female	9 Participants n=10 Participants	9 Participants n=10 Participants	18 Participants n=20 Participants
Sex: Female, Male Male	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Fatigue Severity Scale	51.1 units on a scale STANDARD_DEVIATION 4.1 • n=10 Participants	47.8 units on a scale STANDARD_DEVIATION 9.5 • n=10 Participants	48.5 units on a scale STANDARD_DEVIATION 7.3 • n=20 Participants
Patient Determined Disease Steps (PDDS)	3.5 units on a scale n=10 Participants	2 units on a scale n=10 Participants	3 units on a scale n=20 Participants
BMI	29.1 kg/m^2 n=10 Participants	33.8 kg/m^2 n=10 Participants	32.9 kg/m^2 n=20 Participants
Years Since Diagnosis	4.5 years n=10 Participants	13.5 years n=10 Participants	8 years n=20 Participants

PRIMARY outcome

Timeframe: Baseline (pre) and 8 weeks (post)

Outcome measures

Outcome measures
Measure	In-Person Delivered Exercise n=9 Participants 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.	Telephone-Delivered Exercise n=10 Participants 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.
Daily Average Fatigue Intensity Score Pre	3.9 units on a scale Standard Deviation 1.9	4.4 units on a scale Standard Deviation 1.1
Daily Average Fatigue Intensity Score Post	3.2 units on a scale Standard Deviation 1.9	2.3 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	In-Person Delivered Exercise n=9 Participants 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.	Telephone-Delivered Exercise n=10 Participants 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.
Daily Average Fatigue Interference Score Pre	3.1 units on a scale Standard Deviation 1.9	3.0 units on a scale Standard Deviation 1.3
Daily Average Fatigue Interference Score Post	2.7 units on a scale Standard Deviation 1.8	1.5 units on a scale Standard Deviation 1.7

Adverse Events

In-Person Delivered Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telephone-Delivered Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nora Fritz

Wayne State University

Phone: (313) 577-1096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place