NCT01788397

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

3.3 years

First QC Date

February 7, 2013

Last Update Submit

January 11, 2015

Conditions

Physically Disabled

Keywords

physical disabilitiesrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Short Form 12 v2

    Eight weeks

Secondary Outcomes (3)

  • Pain

    8 weeks

  • Behavioural Regulation in Exercise Questionnaire (BREQ 2)

    8 weeks

  • Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)

    8 weeks

Other Outcomes (1)

  • Self efficacy

    8 weeks

Study Arms (2)

Physical activity

EXPERIMENTAL

Physical activity 2-4 times pr. day

Behavioral: Physical activity

Control group

NO INTERVENTION

No intervention in the control group

Interventions

Physical activityBEHAVIORAL

Swimming, physiotherapy, water therapy, alpine skiing, xc-skiing, hippotherapy, climbing, cycling, rowing

Also known as: Exercise
Physical activity

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with physical disabilities admitted to treatment at BHC

You may not qualify if:

  • Patients with severe cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beitostolen Healtsports Centre

Beitostølen, Oppland, 2953, Norway

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rolf Stalenget

    Beitostolen Healthsports Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

September 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

January 13, 2015

Record last verified: 2015-01

Locations

NO(1)