Introduction
Methods/design
Aims, design, and setting of the study
Participants
Recruitment
Inclusion/exclusion
Inclusion criteria | Exclusion criteria |
---|---|
Screen 1: First Level Criteria | |
Physician-confirmed diagnosis of multiple sclerosis | High risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise using the Physical Activity Readiness Questionnaire [25] |
Relapse and steroid free in the past 30 days | Severe cognitive impairment based on Modified Telephone Interview for Cognitive Status score of less than 18 [26] |
Internet and email access | Current high suicidal risk based on the Columbia-Suicide Severity Rating Scale screening version-recent [27] |
Willingness to complete the testing and questionnaires, wear the accelerometer, undergo randomization, and engage in exercise training | |
Insufficient physical activity based on a Health Contribution Score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire [28] | |
Ability to ambulate without assistance and Patient-Determined Disease Steps score between 0 and 2 (i.e., mild ambulatory disability) [29] | |
Age between 18 and 64 years | |
English as a primary language | |
Not pregnant and/or nursing | |
Screen 2: Second Level Criteria | |
Major Depressive Disorder based on the MINI International Neuropsychiatric Interview [32] | Other severe mental illness (obsessive–compulsive disorder, schizophrenia, bipolar or other psychotic disorders, or recent or current addiction) as indicated by the MINI [32] |
Attrition
Power analysis and sample size
Outcomes
Overview
Primary outcome measures
Self-reported depression severity
Interviewer-rated depression severity
Secondary outcome measures
Fatigue
Cognitive performance
HRQOL
Tertiary outcome measures
Self-reported exercise behavior
Device-measured free-living physical activity
Aerobic capacity
Muscle strength
Random assignment
Intervention condition – home-based aerobic and resistance exercise training
Feature | Description |
---|---|
Prescription | Guidelines for Exercise in MS |
Progressive | |
Individualized | |
Frequency | 3 times per week |
Exercise Session Duration | Approximately 1 h |
Exercise Session Intensity | Moderate |
100 steps/min (pedometer) | |
Rate of Perceived Exertion (RPE) between 11–13 | |
Intervention Length | 16 weeks |
Meeting with Coach | |
Weeks 1–4 | Weekly |
Weeks 5–8 | Bi-weekly |
Weeks 9–16 | Monthly |
Setting | Home |
Supervision | |
Who | Trained personnel |
Mode | Remote, telecoaching |
Exercise Modes | |
Aerobic | Walking |
Resistance | Bands, body weight |
Materials Provided | Program Manual |
Newsletters | |
Logbook | |
Calendar | |
Online Exercise Videos Accessible through QR Code | |
Equipment Provided | Pedometer |
Bands | |
Training Oversight | Zoom/Exercise Videos |
Behavioral Intervention | Zoom |
Intervention Safety | Fall Risk Assessment |
NMSS Resources | |
Fall Prevention Instructions | |
Zoom Oversight and AE/SAE Reporting |
Week | Orange | Blue | Green
| |||
---|---|---|---|---|---|---|
Aerobic training | Resistance training | Aerobic training | Resistance training | Aerobic training | Resistance training | |
Phase I | ||||||
1 | 10 min, ~ 1000 steps | 1S, 10R, 5E | ||||
2 | 10 min, ~ 1000 steps | 1S, 12R, 5E | ||||
Phase II | ||||||
3 | 15 min, ~ 1500 steps | 1S, 15R, 5E | 15 min, ~ 1500 steps | 1S, 12R, 5E | 10 min, ~ 1000 steps | 1S, 12R, 5E |
4 | 20 min, ~ 2000 steps | 2S, 10R, 5E | 15 min, ~ 1500 steps | 1S, 15R, 5E | 15 min, ~ 1500 steps | 1S, 12R, 5E |
5 | 25 min, ~ 2500 steps | 2S, 12R, 5E | 20 min, ~ 2000 steps | 2S, 10R, 5E | 15 min, ~ 1500 steps | 1S, 15R, 5E |
6 | 30 min, ~ 3000 steps | 2S, 15R, 5E | 20 min, ~ 2000 steps | 2S, 12R, 5E | 20 min, ~ 2000 steps | 2S, 10R, 5E |
7 | 30 min, ~ 3000 steps | 2S, 15R, 6E | 25 min, ~ 2500 steps | 2S, 15R, 5E | 20 min, ~ 2000 steps | 2S, 10R, 5E |
8 | 30 min, ~ 3000 steps | 2S, 15R, 6E | 30 min, ~ 3000 steps | 2S, 15R, 5E | 25 min, ~ 2500 steps | 2S, 12R, 5E |
9 | 30 min, ~ 3000 steps | 2S, 15R, 7E | 30 min, ~ 3000 steps | 2S, 15R, 6E | 25 min, ~ 2500 steps | 2S, 12R, 5E |
10 | 30 min, ~ 3000 steps | 2S, 15R, 7E | 30 min, ~ 3000 steps | 2S, 15R, 6E | 30 min, ~ 3000 steps | 2S, 15R, 5E |
11 | 30 min, ~ 3000 steps | 2S, 15R, 8E | 30 min, ~ 3000 steps | 2S, 15R, 7E | 30 min, ~ 3000 steps | 2S, 15R, 6E |
12 | 30 min, ~ 3000 steps | 2S, 15R, 8E | 30 min, ~ 3000 steps | 2S, 15R, 8E | 30 min, ~ 3000 steps | 2S, 15R, 6E |
13 | 30 min, ~ 3000 steps | 2S, 15R, 9E | 30 min, ~ 3000 steps | 2S, 15R, 8E | 30 min, ~ 3000 steps | 2S, 15R, 7E |
14 | 30 min, ~ 3000 steps | 2S, 15R, 9E | 30 min, ~ 3000 steps | 2S, 15R, 9E | 30 min, ~ 3000 steps | 2S, 15R, 8E |
15 | 30 min, ~ 3000 steps | 2S, 15R, 10E | 30 min, ~ 3000 steps | 2S, 15R, 10E | 30 min, ~ 3000 steps | 2S, 15R, 9E |
16 | 30 min, ~ 3000 steps | 2S, 15R, 10E | 30 min, ~ 3000 steps | 2S, 15R, 10E | 30 min, ~ 3000 steps | 2S, 15R, 10E |
Week 1 Introduction to program | Tele/Video-chat 1: Clarification of materials received and initial questions; Explanation of program; Planning exercise schedule; Using the log-book; Newsletter 1; Exercise expectations; Exercise outcomes; Importance of this knowledge |
Week 2 Outcome expectations | Tele/Video-chat 2: Compliance with program; Using the manual and log-book; Identifying personal outcomes |
Week 3 Choosing a program | Tele/Video-chat 3; Compliance with program; Comparison of orange, blue and green programs; Choosing a program; Newsletter 2; Self-monitoring defined; Benefits of self-monitoring; Importance of this knowledge |
Week 4 Self-monitoring | Tele/Video-chat 4: Compliance with program; Using your pedometer; Understanding exercise intensity |
Week 5 Goal-setting | Tele/Video-chat 5: Compliance with program; Setting SMAART goals; Performing resistance training exercises correctly; Tracking progress; Newsletter3; Specific, measurable, adjustable, action-oriented, realistic, and time-limited exercise related goals defined; Importance of this knowledge |
Week 7 Self-efficacy | Tele/Video-chat 6: Finding your self-confidence; What to do when you feel like quitting; Involving family; Newsletter 4; Self-efficacy defined; Experiencing success, choosing role models, accepting encouragement & managing physical and emotional responses; Reminder that program is specific for persons with MS |
Week 11 Overcoming Barriers | Tele/Video-chat 7: Identifying your barriers; Making plans to overcome obstacles; Dealing with MS symptoms; Newsletter 5; Exercise barriers defined; Common barriers (facilities, social & symptoms); Strategies to overcome barriers |
Week 15 Identifying facilitators | Tele/Video-chat 8: How to keep going on your own; Making adjustments as needed; Setting future goals; Newsletter 6; Exercise facilitators defined; Common facilitators (having a goal, enjoyment, social support, knowledge); Using facilitators long term |
Control condition – home-based stretching and flexibility program
Week | Orange | Blue | Green
| |
---|---|---|---|---|
Phase I | ||||
1 | 10 min, 5 categories | 2S, 2E, 15 s | ||
2 | 10 min, 5 categories | 2S, 2E, 15 s | ||
Phase II | ||||
3 | 15 min, 5 categories 2S, 3E, 25 s | 15 min, 5 categories 2S, 3E, 20 s | 10 min, 5 categories 2S, 2E, 15 s | |
4 | 20 min, 5 categories 3S, 3E, 30 s | 15 min, 5 categories 2S, 3E, 20 s | 15 min, 5 categories 2S, 3E, 20 s | |
5 | 25 min, 5 categories 3S, 4E, 45 s | 20 min, 5 categories 2S, 3E, 30 s | 15 min, 5 categories 2S, 3E, 20 s | |
6 | 30 min, 5 categories 4S, 4E, 60 s | 20 min, 5 categories 3S, 3E, 30 s | 20 min, 5 categories 3S, 3E, 30 s | |
7 | 30 min, 6 categories 4S, 4E, 60 s | 25 min, 6 categories 3S, 3E, 45 s | 20 min, 6 categories 3S, 3E, 30 s | |
8 | 30 min, 6 categories 4S, 4E, 60 s | 30 min, 6 categories 4S, 4E, 60 s | 25 min, 6 categories 4S, 3E, 45 s | |
9 | 30 min, 7 categories 4S, 4E, 60 s | 30 min, 7 categories 4S, 4E, 60 s | 25 min, 7 categories 4S, 3E, 45 s | |
10 | 30 min, 7 categories 4S, 4E, 60 s | 30 min, 7 categories 4S, 4E, 60 s | 30 min, 7 categories 4S, 4E, 60 s | |
11 | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | |
12 | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | |
13 | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | |
14 | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | |
15 | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | |
16 | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s | 30 min, 8 categories 4S, 4E, 60 s |
Procedure
Areas of fidelity monitored | ||||||
---|---|---|---|---|---|---|
Data source | Monitoring frequency | Study design | Provider training | Treatment delivery | Treatment receipt | Treatment enactment |
Coaching call checklist | Monthly | × | × | × | ||
Coaching call logs | Monthly | × | × | |||
Auditing of coaching calls by expert | Weekly | × | × | × | × | |
Behavioral resource bank within treatment group | Quarterly | × | ||||
Review of participant exercise logbook | Weekly/ Monthly | × | × | |||
Team meetings to discuss participant progress and protocol adherence | Weekly | × | × | × | × | × |