Clinical trial NCT01057719: Climate Influence on Physiotherapy in Multiple Sclerosis
Official title: Climate Influence on Physiotherapy in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: cross-over design
mixed model
multiple sclerosis
physical performance measures
physical therapy
the Bobath concept
warm climate
6-minute walk test
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University Hospital, Akershus
name: University of Bergen
First posted: 2010-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6-minute walk test
timeFrame: 2 years
Secondary outcomes:
measure: Timed Up&Go
timeFrame: 2 years
measure: 10-metre timed walk
timeFrame: 2
measure: Berg Balance Scale
timeFrame: 2
measure: Trunk Impairment Scale
timeFrame: 2
measure: Borg's Rating of Perceived Exertion
timeFrame: 2
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 2
measure: Fatigue Severity Scale
timeFrame: 2
measure: Numerical Rating Scale; gait, balance, pain
timeFrame: 2
measure: Modified Health Assessment Questionnaire
timeFrame: 2
measure: Patient Global Impression of Change
timeFrame: 2
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Tori Smedal, MSc
role: PRINCIPAL_INVESTIGATOR
References: