Multiple SclerosisNCT01122056
Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
A study testing Physical exercise training in people with Multiple Sclerosis, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the effects and tolerability of exercise on side effects of injectable disease modifying treatments in multiple sclerosis. The investigators main hypothesis is that controlled exercise is safe and can be well tolerated in patients with multiple sclerosis and it can improve… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physical exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to 1 Jun 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver Coastal Health: University of British Columbia Hospital
Vancouver, British Columbia
About this study
The purpose of this study is to investigate the effects and tolerability of exercise on side effects of injectable disease modifying treatments in multiple sclerosis. The investigators main hypothesis is that controlled exercise is safe and can be well tolerated in patients with multiple sclerosis and it can improve disease modifying treatment related side effects such as fatigue.
Read the detailed description
Patient compliance with disease modifying treatment largely depends on relatively common side effects of such treatments such as fatigue. Regular exercise can potentially improve these side effects. However, Safety and effects of exercise has not been studied in patients with multiple sclerosis. Our main aim is to study the safety, tolerability and effects of exercise on side effects of subcutaneous interferon-b1b in patients with Multiple Sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Physical exercise training
- Keywords
- Multiple Sclerosis, b1b-interferon, Fatigue, Exercise
- 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.
Physical exercise trainingOther
Also called Betaseron b1b-interferon, Aerobic exercise
Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis
| Study group | Role | What they receive |
|---|---|---|
| A = Active group | Active comparator | Patients will receive interactive exercise training session from an experienced multiple sclerosis Receives: Other: Physical exercise training |
| B = Control group (Placebo Comparator) | No intervention | Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Fatigue
Quality of Life
Injection site visual analog scale (0-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMay 2010
- Primary completion1 Jun 2012
- Study completion1 Jun 2012
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 British ColumbiaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Sponsor
- Investigators
- Laura Boyd, Study director, University of British ColumbiaKristen Campbell, Study director, University of British ColumbiaSaul Isserow, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122056
- Sponsor's protocol ID
- H10-00277
- Status last verified
- Mar 2017
- First submitted
- 10 May 2010
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01122056
- Acronym / sponsor ID
- H10-00277
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, b1b-interferon, Fatigue, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- May 2010
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 12 May 2010 (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 investigate the effects and tolerability of exercise on side effects of injectable disease modifying treatments in multiple sclerosis. The investigators main hypothesis is that controlled exercise is safe and can be well tolerated in patients with multiple sclerosis and it can improve disease modifying treatment related side effects such as fatigue.
Detailed description
Patient compliance with disease modifying treatment largely depends on relatively common side effects of such treatments such as fatigue. Regular exercise can potentially improve these side effects. However, Safety and effects of exercise has not been studied in patients with multiple sclerosis. Our main aim is to study the safety, tolerability and effects of exercise on side effects of subcutaneous interferon-b1b in patients with Multiple Sclerosis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A = Active group | Active comparator | Other: Physical exercise trainingPatients will receive interactive exercise training session from an experienced multiple sclerosis |
| B = Control group (Placebo Comparator) | No intervention | –Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Physical exercise trainingAlso: Betaseron b1b-interferon, Aerobic exerciseTwo 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis | Other | A = Active group |
Primary outcome
Multiple Sclerosis Fatigue
Quality of Life
Injection site visual analog scale (0-10)
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 Mar 2017.
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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.
Laura Boyd study director
University of British Columbia
Kristen Campbell study director
University of British Columbia
Saul Isserow study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise training in people with Multiple Sclerosis, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 0 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 Mar 2017. 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 Canada. 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?
Multiple Sclerosis Fatigue. The study lists 3 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 Mar 2017.