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Completed

NCT Number: NCT01057719

Climate Influence on Physiotherapy in Multiple Sclerosis

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks

Other names: Physical Therapy, Subtropical climate

Primary outcomes

  1. 6-minute walk test

    Time frame: 2 years

Secondary outcomes

  1. Timed Up&Go

    Time frame: 2 years

  2. 10-metre timed walk

    Time frame: 2

  3. Berg Balance Scale

    Time frame: 2

  4. Trunk Impairment Scale

    Time frame: 2

  5. Borg's Rating of Perceived Exertion

    Time frame: 2

  6. Multiple Sclerosis Impact Scale (MSIS-29)

    Time frame: 2

  7. Fatigue Severity Scale

    Time frame: 2

  8. Numerical Rating Scale; gait, balance, pain

    Time frame: 2

  9. Modified Health Assessment Questionnaire

    Time frame: 2

  10. Patient Global Impression of Change

    Time frame: 2

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Oslo University Hospital
  • University Hospital, Akershus
  • University of Bergen

Registry information

Acronym: CIOPIMS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 27, 2010
Registry last updated
Jan 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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