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Climate Influence on Physiotherapy in Multiple Sclerosis (CIOPIMS)

This study has been completed.
Sponsor:
Collaborators:
Oslo University Hospital
University Hospital, Akershus
University of Bergen
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01057719
First received: January 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Other: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Climate Influence on Physiotherapy in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 6-minute walk test [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timed Up&Go [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 10-metre timed walk [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Berg Balance Scale [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Trunk Impairment Scale [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Borg's Rating of Perceived Exertion [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Fatigue Severity Scale [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Numerical Rating Scale; gait, balance, pain [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Modified Health Assessment Questionnaire [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 2 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057719

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Oslo University Hospital
University Hospital, Akershus
University of Bergen
Investigators
Principal Investigator: Tori Smedal, MSc Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Tori Smedal, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01057719     History of Changes
Other Study ID Numbers: 012.06
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
cross-over design
mixed model
multiple sclerosis
physical performance measures
physical therapy
the Bobath concept
warm climate
6-minute walk test

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014