- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01700933
Dose-response: Exercise Therapy on Hip Osteoarthritis
Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study
Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability. The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a well-documented effect on pain and function in patients with osteoarthritis of the hip. It is sought an optimal dose of exercise, in which this study will help to investigate.
We hypothesize that an exercise program designed to have a high number of repetitions will benefit the outcome of the training in a more positive way than a low-repetition based program.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ørsta, Norway, 6154
- Fysioterapitjenesten i Ørsta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least three month since debut of the disease
- Age above 45 years
- Ability to complete the intervention
Exclusion Criteria:
- Pain above 4 on VAS during gait
- Pregnancy
- Autoimmune disease
- Cardiovascular disease
- Respiratory disease
- Metabolic disease
- Neurological signs
- Planned hip-replacement surgery within the next year
- Received exercise therapy within the last 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High-dosage-group
|
Structure of the exercise program done three times per week, for eight weeks: 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) |
Active Comparator: Low-dosage-group
|
Structure of the exercise program done three times per week, for eight weeks: 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC Index of Osteoarthritis (questionnaire)
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
|
WOMAC Index of Osteoarthritis (questionnaire)
|
0 weeks, 8 weeks, 6 months postinterventional
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HAD questionnaire
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
|
0 weeks, 8 weeks, 6 months postinterventional
|
|
Tampa Scale for Kinesiophobia
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
|
0 weeks, 8 weeks, 6 months postinterventional
|
|
Squats
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
|
Number of squats completed in 30 seconds.
|
0 weeks, 8 weeks, 6 months postinterventional
|
Stairs
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
|
Time used to walk up and down 12 steps.
|
0 weeks, 8 weeks, 6 months postinterventional
|
Collaborators and Investigators
Investigators
- Principal Investigator: Håvard Østerås, Norwegian University of Science and Technology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DROAPS1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Osteoarthritis, Hip
-
Istituto Ortopedico RizzoliRecruiting
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
CHU de ReimsCompleted
-
Royan InstituteCompletedHip OsteoarthritisIran, Islamic Republic of
-
Daiichi Sankyo, Inc.TerminatedSymptomatic Hip OsteoarthritisFrance
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
-
University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
-
Johan KarrholmCompletedPrimary Osteoarthritis of Hip Nos | Secondary Osteoarthritis of Hip
-
Lawson Health Research InstituteCompletedHip Osteoarthritis | Hip ArthroplastyCanada
Clinical Trials on High-Dosage Exercise Therapy
-
Marmara UniversityUnknown
-
Norges idrettshøgskoleKristiania University College; ABEL TechnologiesRecruiting
-
University of South CarolinaCompletedConditionUnited States
-
Norwegian University of Science and TechnologyCompletedPatellofemoral Pain Syndrome
-
Gazi UniversityCompletedTemporomandibular DisorderTurkey
-
Quiropraxia y EquilibrioNot yet recruiting
-
Iran University of Medical SciencesEnrolling by invitationRadiculopathy Lumbar | Radiculopathy, Lumbosacral RegionIran, Islamic Republic of
-
Yonsei UniversityRecruitingGastric Cancer | Pancreatic CancerKorea, Republic of
-
Virginia Polytechnic Institute and State UniversityMedical University of South Carolina; Stanford University; Ohio State University and other collaboratorsRecruitingHemiparesis | Perinatal StrokeUnited States
-
Lama Saad El-Din MahmoudCompletedMultiple SclerosisEgypt