- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01387867
Exercise in Patients With Osteoarthritis of the Hip
Effects of Strength Training and Nordic Walking in Patients With Osteoarthritis of the Hip
According to Danish and international guidelines the recommended first-line of management for people with osteoarthritis consist of exercise, education, analgesic medication, and, if necessary, weight reduction. It is well documented that exercise has a positive effect on pain and physical function in patients with knee OA, but the effect of exercise on hip OA is sparsely investigated.
Aim of the study: To investigate the effects of 1) strength training, and 2) Nordic Walking, and 3) unsupervised home based exercise on muscle function, endurance, pain level, physical activity, and health related quality of life in patients with osteoarthritis of the hip.
The effects of exercise on muscle mass and the mechanisms behind the osteoarthritis, i.e., disease activity, inflammation, and cartilage degradation, are investigated in a subgroup (n=45) of the participants.
Study hypotheses: Strength training will have a greater effect on physical function and muscle strength than Nordic Walking and home based exercise; 2) Nordic Walking will have a greater effect on endurance than strength training and unsupervised home based exercise; 3) Strength training and Nordic Walking will have a greater effect on pain level and health related quality of life than unsupervised home based exercise.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, NV 2400
- Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1)Home-dwelling 60+ year old persons with primary, symptomatic hip OA who meet the clinical criteria of hip OA according to American College of Rheumatology (ACR), and who are not on a waiting list for hip joint replacement.
Exclusion Criteria:
- symptomatic OA in the knee or the big toe,
- joint replacement of the knee or the hip,
- other types of arthritis, e.g., rheumatoid arthritis,
- previous hip fracture,
- limitation in physical function to the extent that using public transportation is impossible,
- co-morbidity that prevents exercising,
- physiotherapy related to hip problems within the last 3 months,
- steroid injections in the hip joint within the last 3 months,
- performing exercise/sports 2+ times weekly, and
- inability to cooperate.
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 |
---|---|
Experimental: Strength training
Strength training three times weekly, i.e.supervised strength training twice weekly and un-supervised strength training once weekly for 4 months.
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Supervised strength training in groups 2 x 1 hour weekly and un-supervised strength training 1 hour weekly for 4 months
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Experimental: Nordic Walking
Nordic walking three times weekly, i.e.Nordic walking twice weekly and un-supervised Nordic walking once weekly for 4 months.
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Supervised Nordic Walking in groups 2 x 1 hour weekly and un-supervised Nordic Walking 1 hour weekly for 4 months
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Active Comparator: Unsupervised home based exercise
The home based unsupervised exercise comprised exercises recommended by the Danish Arthritis Association.
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Unsupervised home based exercise as recommended by the Danish Arthritis Association 1 hour 3 x weekly for 4 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline to 2, 4 and 12 months in number of chair stands in 30 sec at 2, 4 and 12 months
Time Frame: Baseline, 2, 4 and 12 months
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Baseline, 2, 4 and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline to 2, 4 and 12 months in isometric muscle strength (N) of the thigh and hip muscles at 2, 4 and 12 months
Time Frame: Baseline, 2, 4, and 12 months
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Baseline, 2, 4, and 12 months
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Change from Baseline to 2, 4 and 12 months in lower limb extensor muscle power (Watt/kg BW) at 2, 4 and 12 months
Time Frame: Baseline, 2, 4, and 12 months
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Baseline, 2, 4, and 12 months
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Change from Baseline to 2, 4 and 12 months in 6 minute walking distance (m), stair climbing time (s), 15 s marching on the spot (number of knee lifts), Timed-Up-and-Go (s) at 2, 4 and 12 months
Time Frame: Baseline, 2, 4, and 12 months
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Baseline, 2, 4, and 12 months
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Change from Baseline in self-reported pain level at 2, 4 and 12 months
Time Frame: Baseline, 2, 4, and 12 months
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HOOS (Hip dysfunction and Osteoarthritis Outcome Score) and VAS (Visual Analogue scale)
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Baseline, 2, 4, and 12 months
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Change from Baseline in self-reported physical activity at 2, 4 and 12 months
Time Frame: Baseline, 2, 4, and 12 months
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PASE (Physical Activity Scale for the Elderly) and a question from Copenhagen City Heart Study
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Baseline, 2, 4, and 12 months
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Change from Baseline in health related quality of life at 2, 4 and 12 months
Time Frame: Baseline, 2, 4, and 12 months
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SF-36
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Baseline, 2, 4, and 12 months
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Change from Baseline to 4 months in the anatomical cross sectional area (cm2) of the quadriceps femoris muscle measured with MRI. The measurements are performed in a subgroup (15 participants from each group)
Time Frame: Baseline and 4 months
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MRI (magnetic resonance imaging)- The anatomical cross sectional area is measured at mid-thigh level, i.e. 20 cm proximal to the tibia plateau.
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Baseline and 4 months
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Change from Baseline to 4 months in biomarkers of disease activity, inflammation, and cartilage degradation, in a subgroup (15 participants from each group)
Time Frame: Baseline and 4 months
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Blood samples: COMP (cartilage oligomeric matrix protein) and CRP (C-reactive protein)and Urine sample: CTX II (C-terminal telopeptide of collagen II)
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Baseline and 4 months
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Change in task specific self-efficacy from baseline to 2, 4 and 12 months
Time Frame: Baseline, 2, 4 and 12 months
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Self-efficacy in relation to stair climbing performance.
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Baseline, 2, 4 and 12 months
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Change in patient global assessment from baseline to 2, 4 and 12 months.
Time Frame: Baseline to 2, 4 and 12 months
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Baseline to 2, 4 and 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in illness perception from baseline to 12 months
Time Frame: Baseline and 12 months
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Brief Illness Perception Questionnaire
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Baseline and 12 months
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Change in arthritis-specific self-efficacy from baseline to 4 and 12 months
Time Frame: Baseline, 4 and 12 months
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Arthritis-specific Self-efficacy Scale
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Baseline, 4 and 12 months
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Change in perceived competence from baseline to 4 and 12 months
Time Frame: Baseline, 4 and 12 months
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Perceived Competence Scale
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Baseline, 4 and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nina Beyer, Ph.D., Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
Study record dates
Study Major Dates
Study Start
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOA-ISMC
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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