Multiple SclerosisNCT03256851
Telephone-Delivered Exercise for Multiple Sclerosis Fatigue
A study testing Telephone-Delivered Exercise Therapy and In-Person Delivered Exercise Therapy in people with Multiple Sclerosis and Fatigue, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Fatigue, Physical Activity
- What is being tested?
- Telephone-Delivered Exercise Therapy and In-Person Delivered Exercise Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue
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.
- Conditions
- Multiple Sclerosis, Fatigue, Physical Activity
- Being tested
- Telephone-Delivered Exercise Therapy, In-Person Delivered Exercise Therapy
- Medical subject headings
- Multiple Sclerosis, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Delivered Exercise TherapyBehavioural
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.
In-Person Delivered Exercise TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Delivered Exercise | Active comparator | 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. Receives: Behavioral: In-Person Delivered Exercise Therapy |
| Telephone-Delivered Exercise | Experimental | 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 their progress from the prior week, discuss/troubleshoot any issues or problems, and receive progressions of both aerobic and strength training exercises for the upcoming week. Receives: Behavioral: Telephone-Delivered Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline (pre) and 8 weeks (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Jun 2017
- Primary completion31 May 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, University of Michigan
- Responsible party
- Principal investigator, Nora Fritz, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256851
- Sponsor's protocol ID
- 1612000180
- Status last verified
- Oct 2019
- First submitted
- 16 Aug 2017
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31738192
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue
- ClinicalTrials.gov ID
- NCT03256851
- Acronym / sponsor ID
- 1612000180
- Conditions
- Multiple Sclerosis, Fatigue, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, University of Michigan
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 30 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Delivered Exercise | Active comparator | Behavioral: In-Person Delivered Exercise TherapyParticipants 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. |
| Telephone-Delivered Exercise | Experimental | Behavioral: Telephone-Delivered Exercise TherapyParticipants 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 their progress from the prior week, discuss/troubleshoot any issues or problems, and receive progressions of both aerobic and strength training exercises for the upcoming week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-Delivered Exercise TherapyA 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. | Behavioural | Telephone-Delivered Exercise |
| In-Person Delivered Exercise TherapyA 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. | Behavioural | In-Person Delivered Exercise |
Primary outcome
Daily Average Fatigue Intensity Score
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31738192Kratz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Delivered Exercise Therapy and In-Person Delivered Exercise Therapy in people with Multiple Sclerosis and Fatigue, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Average Fatigue Intensity Score (time frame: Baseline (pre) and 8 weeks (post)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.