Multiple SclerosisPhase 2GetFitNCT02457091
Project Get Fit With MS: Guidelines for Exercise Training and Fitness Outcomes in MS
A Phase 2 study testing Resistance exercise and Stretching exercise in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this study is to test different types of exercise training for people with multiple sclerosis (MS). The exercise program is based on physical activity guidelines that have been developed specifically for people with MS. Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Resistance exercise and Stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a definite diagnosis of MS
- self-reported Expanded Disability Status Scale (EDSS) score < 6.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 3.0
- relapse free in past 30 days
- willing and able to visit the University of Illinois at Urbana-Champaign for on seven occasions (two testing visits; five training visits) and participate in a 6-month home-based exercise program
- non-exerciser
- asymptomatic and physician approval for undertaking exercise testing and training
Who cannot join
- currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana-Champaign, Illinois, 61801
About this study
Official title: Project GET FIT With MS: Guidelines for Exercise Training and Fitness Outcomes in MS
The purpose of this study is to test different types of exercise training for people with multiple sclerosis (MS). The exercise program is based on physical activity guidelines that have been developed specifically for people with MS. The investigators believe these guidelines will be effective for improving physical fitness and function in persons with mild-to-moderate MS.
Read the detailed description
Most adults with multiple sclerosis (MS) are physically inactive. One approach to address physical inactivity in this population has involved the provision of physical activity guidelines. Such physical activity guidelines are an important tool for exercise prescription, promotion, and monitoring, and recommend that people with MS "participate in at least 30 minutes of moderate intensity aerobic activity 2 times per week and strength training exercises for major muscle groups 2 times per week." The guidelines were developed from a systematic literature review and have yet to be tested for efficacy in improving fitness or other outcomes. This study will test that efficacy of aerobic and resistance training alone and in combination (based on the MS physical activity guidelines) for improving physical fitness and other outcomes (e.g., walking, thinking, MS symptoms) in persons with MS who have mild-to-moderate disability. Such an examination will be important to confirm the efficacy of the exercise prescription for people with MS and health-care providers. The investigators will further perform an exploratory analysis of blood biomarkers and eye imaging parameters to examine some of the mechanisms of exercise training effects in persons with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Resistance exercise, Stretching exercise
- Keywords
- multiple sclerosis, exercise, home-based, training, fitness
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseBehavioural
strength training consists of 1-3 sets , 10-15 repetitions of 10 exercises targeting lower body, upper body and core muscle groups
Stretching exerciseBehavioural
The stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week.
| Study group | Role | What they receive |
|---|---|---|
| Stretching exercise | Active comparator | The stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week. Receives: Behavioral: Stretching exercise |
| Resistance exercise | Experimental | The resistance condition will consist of 1-3 sets, 10-15 repetitions of 12 exercises targeting lower body, upper body, and core muscle groups performed 2 days per week. Receives: Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical fitness (aerobic and muscular)
Physical fitness determined by VO2 peak using a computer-driven cycle ergometer Muscular fitness determined by a seated dynamometer machine for leg strength and a hand dynamometer for upper body strength
Measured: 0 and 6 months
Walking and physical function
A timed 25-Foot walk, a 6 -minute walk, walking on a GaitRite electronic walkway, 9-hole peg test and the use of a force platform will measure walking and physical function.
Measured: 0 and 6 months
Cognition
The Brief International Cognitive Assessment for MS battery will be used.
Measured: 0 and 6 months
Physical activity
an accelerometer along with the Godin Leisure Time Physical Activity Questionnaire and 7-day Physical Activity Recall Questionnaire will be used to measure physical activity.
Measured: 0 and 6 months
Patient-rated outcomes
Self reporting questionnaires on fatigue, mobility, anxiety, depression, QoL, and social cognitive theory variable (e.g. Exercise Self-Efficacy Scale, Late-life function and disability scale)
Measured: 0 and 6 months
Secondary outcomes (4)
Body composition
DXA scan
Measured: 0 and 6 months
OCT Eye imaging
Measured: 0 and 6 months
Cardiovascular function
ultrasonography techniques for arterial size, stiffness and blood pressure along with an ECG
Measured: 0 and 6 months
Blood biomarkers
Circulating inflammatory markers, cytokines and growth factors
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lara Pilutti, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457091
- Sponsor's protocol ID
- NMSS IL-0010
- Acronym
- GetFit
- Status last verified
- Dec 2015
- First submitted
- 17 Mar 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project GET FIT With MS: Guidelines for Exercise Training and Fitness Outcomes in MS
- ClinicalTrials.gov ID
- NCT02457091
- Acronym / sponsor ID
- GetFit / NMSS IL-0010
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, exercise, home-based, training, fitness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test different types of exercise training for people with multiple sclerosis (MS). The exercise program is based on physical activity guidelines that have been developed specifically for people with MS. The investigators believe these guidelines will be effective for improving physical fitness and function in persons with mild-to-moderate MS.
Detailed description
Most adults with multiple sclerosis (MS) are physically inactive. One approach to address physical inactivity in this population has involved the provision of physical activity guidelines. Such physical activity guidelines are an important tool for exercise prescription, promotion, and monitoring, and recommend that people with MS "participate in at least 30 minutes of moderate intensity aerobic activity 2 times per week and strength training exercises for major muscle groups 2 times per week." The guidelines were developed from a systematic literature review and have yet to be tested for efficacy in improving fitness or other outcomes. This study will test that efficacy of aerobic and resistance training alone and in combination (based on the MS physical activity guidelines) for improving physical fitness and other outcomes (e.g., walking, thinking, MS symptoms) in persons with MS who have mild-to-moderate disability. Such an examination will be important to confirm the efficacy of the exercise prescription for people with MS and health-care providers. The investigators will further perform an exploratory analysis of blood biomarkers and eye imaging parameters to examine some of the mechanisms of exercise training effects in persons with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching exercise | Active comparator | Behavioral: Stretching exerciseThe stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week. |
| Resistance exercise | Experimental | Behavioral: Resistance exerciseThe resistance condition will consist of 1-3 sets, 10-15 repetitions of 12 exercises targeting lower body, upper body, and core muscle groups performed 2 days per week. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- a definite diagnosis of MS
- self-reported Expanded Disability Status Scale (EDSS) score < 6.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 3.0
- relapse free in past 30 days
- willing and able to visit the University of Illinois at Urbana-Champaign for on seven occasions (two testing visits; five training visits) and participate in a 6-month home-based exercise program
- non-exerciser
Key exclusion criteria (1 listed)
- currently pregnant
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 |
|---|---|---|
| Resistance exercisestrength training consists of 1-3 sets , 10-15 repetitions of 10 exercises targeting lower body, upper body and core muscle groups | Behavioural | Resistance exercise |
| Stretching exerciseThe stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week. | Behavioural | Stretching exercise |
Primary outcome
Physical fitness (aerobic and muscular)
Time frame: 0 and 6 months
Physical fitness determined by VO2 peak using a computer-driven cycle ergometer Muscular fitness determined by a seated dynamometer machine for leg strength and a hand dynamometer for upper body strength
Walking and physical function
Time frame: 0 and 6 months
A timed 25-Foot walk, a 6 -minute walk, walking on a GaitRite electronic walkway, 9-hole peg test and the use of a force platform will measure walking and physical function.
Cognition
Time frame: 0 and 6 months
The Brief International Cognitive Assessment for MS battery will be used.
Physical activity
Time frame: 0 and 6 months
an accelerometer along with the Godin Leisure Time Physical Activity Questionnaire and 7-day Physical Activity Recall Questionnaire will be used to measure physical activity.
Patient-rated outcomes
Time frame: 0 and 6 months
Self reporting questionnaires on fatigue, mobility, anxiety, depression, QoL, and social cognitive theory variable (e.g. Exercise Self-Efficacy Scale, Late-life function and disability scale)
4 secondary outcomes
Body composition
Time frame: 0 and 6 months
OCT Eye imaging
Time frame: 0 and 6 months
Cardiovascular function
Time frame: 0 and 6 months
Blood biomarkers
Time frame: 0 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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.
Lara Pilutti, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resistance exercise and Stretching exercise in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign 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 6 inclusion and 1 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 3 Dec 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical fitness (aerobic and muscular) (time frame: 0 and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2015.