Hip OsteoarthritisNCT01387867
Exercise in Patients With Osteoarthritis of the Hip
A study testing Strength training, Nordic Walking and Unsupervised home based exercise in people with Hip Osteoarthritis, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Strength training, Nordic Walking and Unsupervised home based exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Jan 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
Copenhagen, NV 2400
About this study
Official title: 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.
Read more
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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Strength training, Nordic Walking, Unsupervised home based exercise
- Keywords
- Exercise, Hip osteoarthritis, Randomized controlled trial
- Medical subject headings
- Osteoarthritis, Hip, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingProcedure or surgery
Supervised strength training in groups 2 x 1 hour weekly and un-supervised strength training 1 hour weekly for 4 months
Nordic WalkingProcedure or surgery
Supervised Nordic Walking in groups 2 x 1 hour weekly and un-supervised Nordic Walking 1 hour weekly for 4 months
Unsupervised home based exerciseProcedure or surgery
Unsupervised home based exercise as recommended by the Danish Arthritis Association 1 hour 3 x weekly for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Strength training three times weekly, i.e.supervised strength training twice weekly and un-supervised strength training once weekly for 4 months. Receives: Procedure: Strength training |
| Nordic Walking | Experimental | Nordic walking three times weekly, i.e.Nordic walking twice weekly and un-supervised Nordic walking once weekly for 4 months. Receives: Procedure: Nordic Walking |
| Unsupervised home based exercise | Active comparator | The home based unsupervised exercise comprised exercises recommended by the Danish Arthritis Association. Receives: Procedure: Unsupervised home based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 2, 4 and 12 months in number of chair stands in 30 sec at 2, 4 and 12 months
Measured: Baseline, 2, 4 and 12 months
Secondary outcomes (10)
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
Measured: Baseline, 2, 4, and 12 months
Change from Baseline to 2, 4 and 12 months in lower limb extensor muscle power (Watt/kg BW) at 2, 4 and 12 months
Measured: Baseline, 2, 4, and 12 months
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
Measured: Baseline, 2, 4, and 12 months
Change from Baseline in self-reported pain level at 2, 4 and 12 months
HOOS (Hip dysfunction and Osteoarthritis Outcome Score) and VAS (Visual Analogue scale)
Measured: Baseline, 2, 4, and 12 months
Change from Baseline in self-reported physical activity at 2, 4 and 12 months
PASE (Physical Activity Scale for the Elderly) and a question from Copenhagen City Heart Study
Measured: Baseline, 2, 4, and 12 months
Change from Baseline in health related quality of life at 2, 4 and 12 months
SF-36
Measured: Baseline, 2, 4, and 12 months
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)
MRI (magnetic resonance imaging)- The anatomical cross sectional area is measured at mid-thigh level, i.e. 20 cm proximal to the tibia plateau.
Measured: Baseline and 4 months
Change from Baseline to 4 months in biomarkers of disease activity, inflammation, and cartilage degradation, in a subgroup (15 participants from each group)
Blood samples: COMP (cartilage oligomeric matrix protein) and CRP (C-reactive protein)and Urine sample: CTX II (C-terminal telopeptide of collagen II)
Measured: Baseline and 4 months
Change in task specific self-efficacy from baseline to 2, 4 and 12 months
Self-efficacy in relation to stair climbing performance.
Measured: Baseline, 2, 4 and 12 months
Change in patient global assessment from baseline to 2, 4 and 12 months.
Measured: Baseline to 2, 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startOct 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Nina Beyer, Bispebjerg Hospital
- Investigators
- Nina Beyer, Ph.D., Principal investigator, Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387867
- Sponsor's protocol ID
- HOA-ISMC
- Status last verified
- Jul 2013
- First submitted
- 29 Jun 2011
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strength Training and Nordic Walking in Patients With Osteoarthritis of the Hip
- ClinicalTrials.gov ID
- NCT01387867
- Acronym / sponsor ID
- HOA-ISMC
- Conditions
- Hip Osteoarthritis
- Keywords
- Exercise, Hip osteoarthritis, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Jul 2011 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Procedure: Strength trainingStrength training three times weekly, i.e.supervised strength training twice weekly and un-supervised strength training once weekly for 4 months. |
| Nordic Walking | Experimental | Procedure: Nordic WalkingNordic walking three times weekly, i.e.Nordic walking twice weekly and un-supervised Nordic walking once weekly for 4 months. |
| Unsupervised home based exercise | Active comparator | Procedure: Unsupervised home based exerciseThe home based unsupervised exercise comprised exercises recommended by the Danish Arthritis Association. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| Strength trainingSupervised strength training in groups 2 x 1 hour weekly and un-supervised strength training 1 hour weekly for 4 months | Procedure or surgery | Strength training |
| Nordic WalkingSupervised Nordic Walking in groups 2 x 1 hour weekly and un-supervised Nordic Walking 1 hour weekly for 4 months | Procedure or surgery | Nordic Walking |
| Unsupervised home based exerciseUnsupervised home based exercise as recommended by the Danish Arthritis Association 1 hour 3 x weekly for 4 months | Procedure or surgery | Unsupervised home based exercise |
Primary outcome
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
10 secondary outcomes
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
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
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
Change from Baseline in self-reported pain level at 2, 4 and 12 months
Time frame: Baseline, 2, 4, and 12 months
Change from Baseline in self-reported physical activity at 2, 4 and 12 months
Time frame: Baseline, 2, 4, and 12 months
Change from Baseline in health related quality of life at 2, 4 and 12 months
Time frame: Baseline, 2, 4, and 12 months
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
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
Change in task specific self-efficacy from baseline to 2, 4 and 12 months
Time frame: Baseline, 2, 4 and 12 months
Change in patient global assessment from baseline to 2, 4 and 12 months.
Time frame: Baseline to 2, 4 and 12 months
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 6 Feb 2015.
Related trials for Hip Osteoarthritis
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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.
Nina Beyer, Ph.D. principal investigator
Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training, Nordic Walking and Unsupervised home based exercise in people with Hip Osteoarthritis, run by Bispebjerg Hospital at 1 site in Denmark.
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 10 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 6 Feb 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 Denmark. 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?
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). 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 6 Feb 2015.