Physically DisabledNCT01788397
Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre
A study testing Physical activity in people with Physically Disabled, run by Beitostølen Health Sports Center at 1 site in Norway.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Physically Disabled
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with physical disabilities admitted to treatment at BHC
Who cannot join
- Patients with severe cognitive disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
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- Conditions
- Physically Disabled
- Being tested
- Physical activity
- Keywords
- physical disabilities, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Also called Exercise
Swimming, physiotherapy, water therapy, alpine skiing, xc-skiing, hippotherapy, climbing, cycling, rowing
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Physical activity 2-4 times pr. day Receives: Behavioral: Physical activity |
| Control group | No intervention | No intervention in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Short Form 12 v2
Measured: Eight weeks
Secondary outcomes (3)
Pain
VAS Pain
Measured: 8 weeks
Behavioural Regulation in Exercise Questionnaire (BREQ 2)
Measures motivational regulation
Measured: 8 weeks
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Measures Physical Activity level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physically DisabledStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beitostølen Health Sports Center
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Hakon Dalen, Beitostølen Health Sports Center
- Investigators
- Rolf Stalenget, Study director, Beitostolen Healthsports Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788397
- Sponsor's protocol ID
- BHSS
- Status last verified
- Jan 2015
- First submitted
- 7 Feb 2013
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre. A Randomized Study.
- ClinicalTrials.gov ID
- NCT01788397
- Acronym / sponsor ID
- BHSS
- Conditions
- Physically Disabled
- Keywords
- physical disabilities, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Beitostølen Health Sports CenterUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activityPhysical activity 2-4 times pr. day |
| Control group | No intervention | –No intervention in the control group |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with physical disabilities admitted to treatment at BHC
Key exclusion criteria (1 listed)
- Patients with severe cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: ExerciseSwimming, physiotherapy, water therapy, alpine skiing, xc-skiing, hippotherapy, climbing, cycling, rowing | Behavioural | Physical activity |
Primary outcome
Quality of life
Time frame: Eight weeks
Short Form 12 v2
3 secondary outcomes
Pain
Time frame: 8 weeks
Behavioural Regulation in Exercise Questionnaire (BREQ 2)
Time frame: 8 weeks
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Stalenget study director
Beitostolen Healthsports Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Physically Disabled, run by Beitostølen Health Sports Center at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.