Climate Influence on Physiotherapy in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Physiotherapy

• Registration Number: NCT01057719
• Lead Sponsor: Haukeland University Hospital

Brief 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.

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 Timeline

• Study Start: 2006-06
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2010-01
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Last Update Submitted: 2010-01-26
• Study First Posted: 2010-01-27
• Last Update Posted: 2010-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physiotherapy in Spain	Physiotherapy	Daily inpatient physiotherapy for four weeks in a warm climate
Physiotherapy in Norway	Physiotherapy	Daily inpatient physiotherapy for four weeks in a cold climate

Primary Outcome Measures

Name	Time	Method
6-minute walk test	2 years

Secondary Outcome Measures

Name	Time	Method
Trunk Impairment Scale	2
Timed Up&Go	2 years
10-metre timed walk	2
Berg Balance 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

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway