Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
| University of Michigan | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person Delivered Exercise | Active Comparator | Participants in the in-person training group will:
|
|
| Telephone-Delivered Exercise | Experimental | Participants in the telephone-delivered training group will:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-Delivered Exercise Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre) and 8 weeks (post) |
| 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). | Baseline (pre) and 8 weeks (post) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31738192 | Derived | Kratz AL, Atalla M, Whibley D, Myles A, Thurston T, Fritz NE. Calling Out MS Fatigue: Feasibility and Preliminary Effects of a Pilot Randomized Telephone-Delivered Exercise Intervention for Multiple Sclerosis Fatigue. J Neurol Phys Ther. 2020 Jan;44(1):23-31. doi: 10.1097/NPT.0000000000000296. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | In-Person Delivered Exercise | Participants in the in-person training group will:
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. |
| FG001 | Telephone-Delivered Exercise | Participants in the telephone-delivered training group will:
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | In-Person Delivered Exercise | Participants in the in-person training group will:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre) and 8 weeks (post) |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-Person Delivered Exercise | Participants in the in-person training group will:
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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nora Fritz | Wayne State University | (313) 577-1096 | nora.fritz@wayne.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2018 | Oct 7, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| In-Person Delivered Exercise Therapy | Behavioral | 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. |
|
| BG001 | Telephone-Delivered Exercise | Participants in the telephone-delivered training group will:
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fatigue Severity Scale | The Fatigue Severity Scale is a 9-item questionnaire in which participants rate their fatigue from 1-7 for each question. A higher score (max total = 63) indicates worse fatigue. The total score is reported. The range of possible scores is 9-63. | Mean | Standard Deviation | units on a scale |
|
| Patient Determined Disease Steps (PDDS) | The PDDS requires a single response on a 0-8 scale that indicates the person's perceived level of disability from 0 (normal - I have some mild symptoms, mostly sensory due to MS but they do not limit my activity) to 8 (bedridden- unable to sit in a wheelchair for more than one hour). The total score is reported, with higher numbers indicating worse disability. | Mean | Inter-Quartile Range | units on a scale |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Years Since Diagnosis | Median | Inter-Quartile Range | years |
|
| OG001 | Telephone-Delivered Exercise | Participants in the telephone-delivered training group will:
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. |
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre) and 8 weeks (post) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Telephone-Delivered Exercise | Participants in the telephone-delivered training group will:
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. | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |