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Climate Influence on Physiotherapy in Multiple Sclerosis (CIOPIMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring cross-over design, mixed model, multiple sclerosis, physical performance measures, physical therapy, the Bobath concept, warm climate, 6-minute walk test

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Physiotherapy in Spain

Physiotherapy in Norway

Arm Description

Daily inpatient physiotherapy for four weeks in a warm climate

Daily inpatient physiotherapy for four weeks in a cold climate

Outcomes

Primary Outcome Measures

6-minute walk test

Secondary Outcome Measures

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

Full Information

First Posted
January 26, 2010
Last Updated
January 26, 2010
Sponsor
Haukeland University Hospital
Collaborators
Oslo University Hospital, University Hospital, Akershus, University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT01057719
Brief Title
Climate Influence on Physiotherapy in Multiple Sclerosis
Acronym
CIOPIMS
Official Title
Climate Influence on Physiotherapy in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Haukeland University Hospital
Collaborators
Oslo University Hospital, University Hospital, Akershus, University of Bergen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
cross-over design, mixed model, multiple sclerosis, physical performance measures, physical therapy, the Bobath concept, warm climate, 6-minute walk test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy in Spain
Arm Type
Experimental
Arm Description
Daily inpatient physiotherapy for four weeks in a warm climate
Arm Title
Physiotherapy in Norway
Arm Type
Experimental
Arm Description
Daily inpatient physiotherapy for four weeks in a cold climate
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Physical Therapy, Subtropical climate
Intervention Description
Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks
Primary Outcome Measure Information:
Title
6-minute walk test
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Timed Up&Go
Time Frame
2 years
Title
10-metre timed walk
Time Frame
2
Title
Berg Balance Scale
Time Frame
2
Title
Trunk Impairment Scale
Time Frame
2
Title
Borg's Rating of Perceived Exertion
Time Frame
2
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame
2
Title
Fatigue Severity Scale
Time Frame
2
Title
Numerical Rating Scale; gait, balance, pain
Time Frame
2
Title
Modified Health Assessment Questionnaire
Time Frame
2
Title
Patient Global Impression of Change
Time Frame
2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tori Smedal, MSc
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

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Climate Influence on Physiotherapy in Multiple Sclerosis

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