Climate Influence on Physiotherapy in Multiple Sclerosis (CIOPIMS)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Physiotherapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapy in Spain; Daily inpatient physiotherapy for four weeks in a warm climate	Other: Physiotherapy; Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks; Other Names: Physical Therapy; Subtropical climate
Experimental: Physiotherapy in Norway; Daily inpatient physiotherapy for four weeks in a cold climate	Other: Physiotherapy; Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks; Other Names: Physical Therapy; Subtropical climate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6-minute walk test	2 years

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Oslo University Hospital; University of Bergen; University Hospital, Akershus
• Investigators: Principal Investigator: Tori Smedal, MSc, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (Estimate): January 27, 2010

Study Record Updates

• Last Update Posted (Estimate): January 27, 2010
• Last Update Submitted That Met QC Criteria: January 26, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: multiple sclerosis; physical therapy; cross-over design; 6-minute walk test; mixed model; physical performance measures; the Bobath concept; warm climate
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 012.06