Multiple SclerosisCIOPIMSNCT01057719
Climate Influence on Physiotherapy in Multiple Sclerosis
A study testing Physiotherapy in people with Multiple Sclerosis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The aim of the study was to compare the effect of inpatient physiotherapy in a warm climate versus physiotherapy in a colder climate in multiple sclerosis (MS), in both short- and long term perspectives. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2006to May 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 60 years of age (both included).
- Multiple sclerosis according to the McDonald criteria
- Disability equivalent to Expanded Disability Status Score (EDSS) between 4.0 and 6.5 (both included)
- Prepared to and considered able to follow the protocol and to attend the planned visits during the whole study period.
- Given written informed consent
Who cannot join
- An active MS (attack or progression) during one month prior to inclusion or start of treatment.
- Received treatment with glucocorticoids the last month prior to inclusion or start of treatment.
- Excessive fatigue or severe cognitive dysfunction related to MS that would preclude safe participation in the protocol.
- Suffered from major depression or any other psychiatric disorder that would preclude safe participation in the protocol.
- Heat intolerance.
- Other serious concomitant disease that could preclude safe participation in the protocol.
- Alcohol or drug abuse or consumption that could preclude participation according to the protocol and to attend the planned visits during the whole study period.
- Breastfeeding or pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to compare the effect of inpatient physiotherapy in a warm climate versus physiotherapy in a colder climate in multiple sclerosis (MS), in both short- and long term perspectives.
Read the detailed description
Empirically, several patients with MS have reported improved function in warm climate during therapy or vacation. This is in contrast to the heat intolerance frequently reported in MS. Heat intolerance seems, however, to be individually distributed among the MS patients, and may seem to be related to the degree of warmth.
Sixty patients with gait problems and without heat intolerance were included in a cross-over study. They were randomized to a 4-week inpatient physiotherapy based on the Bobath concept in Norway or Spain, with cross-over the year after. Data from five physical performance measures and six self-reported measures were collected at screening, baseline, after treatment and three and six months after both treatment-periods. Change over time within groups and comparisons of change between groups were analyzed by mixed models.
- Conditions
- Multiple Sclerosis
- Being tested
- Physiotherapy
- Keywords
- cross-over design, mixed model, multiple sclerosis, physical performance measures, physical therapy, the Bobath concept, warm climate, 6-minute walk test
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called Physical Therapy, Subtropical climate
Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy in Spain | Experimental | Daily inpatient physiotherapy for four weeks in a warm climate Receives: Other: Physiotherapy |
| Physiotherapy in Norway | Experimental | Daily inpatient physiotherapy for four weeks in a cold climate Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Measured: 2 years
Secondary outcomes (10)
Timed Up&Go
Measured: 2 years
10-metre timed walk
Measured: 2
Berg Balance Scale
Measured: 2
Trunk Impairment Scale
Measured: 2
Borg's Rating of Perceived Exertion
Measured: 2
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: 2
Fatigue Severity Scale
Measured: 2
Numerical Rating Scale; gait, balance, pain
Measured: 2
Modified Health Assessment Questionnaire
Measured: 2
Patient Global Impression of Change
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionMay 2008
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus, University of Bergen
- Investigators
- Tori Smedal, MSc, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057719
- Sponsor's protocol ID
- 012.06
- Acronym
- CIOPIMS
- Status last verified
- Jan 2010
- First submitted
- 26 Jan 2010
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Climate Influence on Physiotherapy in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01057719
- Acronym / sponsor ID
- CIOPIMS / 012.06
- Conditions
- Multiple Sclerosis
- Keywords
- cross-over design, mixed model, multiple sclerosis, physical performance measures, physical therapy, the Bobath concept, warm climate, 6-minute walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus, University of Bergen
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Jan 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 aim of the study was to compare the effect of inpatient physiotherapy in a warm climate versus physiotherapy in a colder climate in multiple sclerosis (MS), in both short- and long term perspectives.
Detailed description
Empirically, several patients with MS have reported improved function in warm climate during therapy or vacation. This is in contrast to the heat intolerance frequently reported in MS. Heat intolerance seems, however, to be individually distributed among the MS patients, and may seem to be related to the degree of warmth.
Sixty patients with gait problems and without heat intolerance were included in a cross-over study. They were randomized to a 4-week inpatient physiotherapy based on the Bobath concept in Norway or Spain, with cross-over the year after. Data from five physical performance measures and six self-reported measures were collected at screening, baseline, after treatment and three and six months after both treatment-periods. Change over time within groups and comparisons of change between groups were analyzed by mixed models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy in Spain | Experimental | Other: PhysiotherapyDaily inpatient physiotherapy for four weeks in a warm climate |
| Physiotherapy in Norway | Experimental | Other: PhysiotherapyDaily inpatient physiotherapy for four weeks in a cold climate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 18 and 60 years of age (both included).
- Multiple sclerosis according to the McDonald criteria
- Disability equivalent to Expanded Disability Status Score (EDSS) between 4.0 and 6.5 (both included)
- Prepared to and considered able to follow the protocol and to attend the planned visits during the whole study period.
- Given written informed consent
Key exclusion criteria (8 listed)
- An active MS (attack or progression) during one month prior to inclusion or start of treatment.
- Received treatment with glucocorticoids the last month prior to inclusion or start of treatment.
- Excessive fatigue or severe cognitive dysfunction related to MS that would preclude safe participation in the protocol.
- Suffered from major depression or any other psychiatric disorder that would preclude safe participation in the protocol.
- Heat intolerance.
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 |
|---|---|---|
| PhysiotherapyAlso: Physical Therapy, Subtropical climateIndividual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks | Other | Physiotherapy in Norway, Physiotherapy in Spain |
Primary outcome
6-minute walk test
Time frame: 2 years
10 secondary outcomes
Timed Up&Go
Time frame: 2 years
10-metre timed walk
Time frame: 2
Berg Balance Scale
Time frame: 2
Trunk Impairment Scale
Time frame: 2
Borg's Rating of Perceived Exertion
Time frame: 2
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 2
Fatigue Severity Scale
Time frame: 2
Numerical Rating Scale; gait, balance, pain
Time frame: 2
Modified Health Assessment Questionnaire
Time frame: 2
Patient Global Impression of Change
Time frame: 2
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 27 Jan 2010.
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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.
Tori Smedal, MSc principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Multiple Sclerosis, run by Haukeland University Hospital at 1 site in Norway.
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 8 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 27 Jan 2010. 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 Norway. 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?
6-minute walk test (time frame: 2 years). 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 27 Jan 2010; AzTrials last refreshed its copy on 27 Oct 2026.