- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788397
Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre
January 11, 2015 updated by: Hakon Dalen, Beitostølen Health Sports Center
Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre. A Randomized Study.
The main hypothesis:
The participants receive treatment at Beitostølen within 8 weeks or within 16 weeks. The groups waiting for rehabilitation is compared with the group receiving rehabilitation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
nn
Study Type
Interventional
Enrollment (Actual)
247
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oppland
-
Beitostolen, Oppland, Norway, 2953
- Beitostolen Healtsports Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with physical disabilities admitted to treatment at BHC
Exclusion Criteria:
- Patients with severe cognitive disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Physical activity
Physical activity 2-4 times pr.
day
|
Swimming, physiotherapy, water therapy, alpine skiing, xc-skiing, hippotherapy, climbing, cycling, rowing
Other Names:
|
|
NO_INTERVENTION: Control group
No intervention in the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: Eight weeks
|
Short Form 12 v2
|
Eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: 8 weeks
|
VAS Pain
|
8 weeks
|
|
Behavioural Regulation in Exercise Questionnaire (BREQ 2)
Time Frame: 8 weeks
|
Measures motivational regulation
|
8 weeks
|
|
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Time Frame: 8 weeks
|
Measures Physical Activity level
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self efficacy
Time Frame: 8 weeks
|
Self-Efficacy for Managing Chronic Disease 6-Item Scale; Exercise Regularly Scale (3-item scale); Social/Recreational Activities Scale (2-item scale); Stanford Patient Education Research Centre: Lorig K, Stewart A, Ritter P, González V, Laurent D, & Lynch J, Outcome Measures for Health Education and other Health Care Interventions.
Thousand Oaks CA: Sage Publications, 1996, pp.24-25,41-45.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Rolf Stalenget, Beitostolen Healthsports Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
February 7, 2013
First Submitted That Met QC Criteria
February 7, 2013
First Posted (ESTIMATE)
February 11, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 13, 2015
Last Update Submitted That Met QC Criteria
January 11, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BHSS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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