Climate Influence on Physiotherapy in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Climate Influence on Physiotherapy in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy in Spain<br>Daily inpatient physiotherapy for four weeks in a warm climate | Other: Physiotherapy<br>* Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks<br>* Other names: Subtropical climate;|
| Experimental: Physiotherapy in Norway<br>Daily inpatient physiotherapy for four weeks in a cold climate | Other: Physiotherapy<br>* Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks<br>* Other names: Subtropical climate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up&Go |  | 2 years | 
| 10-metre timed walk |  | 2 | 
| Berg Balance Scale |  | 2 | 
| Trunk Impairment Scale |  | 2 | 
| Borg's Rating of Perceived Exertion |  | 2 | 
| Multiple Sclerosis Impact Scale (MSIS-29) |  | 2 | 
| Fatigue Severity Scale |  | 2 | 
| Numerical Rating Scale; gait, balance, pain |  | 2 | 
| Modified Health Assessment Questionnaire |  | 2 | 
| Patient Global Impression of Change |  | 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cross-over design, mixed model, multiple sclerosis, physical performance measures, physical therapy, the Bobath concept, warm climate, 6-minute walk test