Multiple SclerosisNCT00513448
Promoting Physical Activity for Persons With Multiple Sclerosis
A study testing Group wellness intervention and Individualized physical rehabilitation in people with Multiple Sclerosis, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study was to determine whether a group wellness intervention or individualized physical rehabilitation was more effective in improving health and physical activity in persons with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Group wellness intervention and Individualized physical rehabilitation
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Nov 2005
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A physician-confirmed diagnosis of MS
- Between the ages of 18 to 75 years
- Ability to ambulate 25 meters with or without the use of an adaptive aide
Who cannot join
- Pregnant
- Cardiovascular disease
- Had fallen more than twice in the past month
- Significant cognitive deficits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Comparing Individualized Rehabilitation to a Group Wellness Intervention for Persons With Multiple Sclerosis
The purpose of this study was to determine whether a group wellness intervention or individualized physical rehabilitation was more effective in improving health and physical activity in persons with multiple sclerosis.
Read the detailed description
Evidence from this study shows that both interventions were effective in improving health and physical activity in persons with multiple sclerosis. The results also show that participants may benefit more physically from individualized physical rehabilitation and more mentally from group wellness interventions. Interventions that combine individualized therapeutic exercise with group health education might be most effective for persons with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Group wellness intervention, Individualized physical rehabilitation
- Keywords
- Chronic Disabling Condition, Comparative Evaluation, Physical Activity, Physical Therapy, Rehabilitation
- 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.
Group wellness interventionOther
Individualized physical rehabilitationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Impact Scale SF-36 Mental Health Inventory
Measured: 16 weeks
Secondary outcomes (1)
Physical assessments
Measured: 16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startApr 2005
- Study completionNov 2005
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.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Matthew A Plow, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513448
- Sponsor's protocol ID
- 0311M53442
- Status last verified
- Aug 2007
- First submitted
- 7 Aug 2007
- Last updated
- 8 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Individualized Rehabilitation to a Group Wellness Intervention for Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00513448
- Acronym / sponsor ID
- 0311M53442
- Conditions
- Multiple Sclerosis
- Keywords
- Chronic Disabling Condition, Comparative Evaluation, Physical Activity, Physical Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2005
- Study completion
- Nov 2005 (actual)
- First posted
- 8 Aug 2007 (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 was to determine whether a group wellness intervention or individualized physical rehabilitation was more effective in improving health and physical activity in persons with multiple sclerosis.
Detailed description
Evidence from this study shows that both interventions were effective in improving health and physical activity in persons with multiple sclerosis. The results also show that participants may benefit more physically from individualized physical rehabilitation and more mentally from group wellness interventions. Interventions that combine individualized therapeutic exercise with group health education might be most effective for persons with multiple sclerosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A physician-confirmed diagnosis of MS
- Between the ages of 18 to 75 years
- Ability to ambulate 25 meters with or without the use of an adaptive aide
Key exclusion criteria (4 listed)
- Pregnant
- Cardiovascular disease
- Had fallen more than twice in the past month
- Significant cognitive deficits
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 |
|---|---|---|
| Group wellness intervention | Other | – |
| Individualized physical rehabilitation | Other | – |
Primary outcome
Modified Fatigue Impact Scale SF-36 Mental Health Inventory
Time frame: 16 weeks
1 secondary outcome
Physical assessments
Time frame: 16-weeks
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 8 Aug 2007.
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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.
Matthew A Plow, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group wellness intervention and Individualized physical rehabilitation in people with Multiple Sclerosis, run by University of Minnesota 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 3 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 8 Aug 2007. 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?
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?
Modified Fatigue Impact Scale SF-36 Mental Health Inventory (time frame: 16 weeks). 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 8 Aug 2007.