Osteoarthritis, HipNCT01700933
Dose-response: Exercise Therapy on Hip Osteoarthritis
A study testing High-Dosage Exercise Therapy and Low-Dosage Exercise Therapy in people with Osteoarthritis, Hip, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- High-Dosage Exercise Therapy and Low-Dosage Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least three month since debut of the disease
- Age above 45 years
- Ability to complete the intervention
Who cannot join
- Pain above 4 on VAS during gait
- Pregnancy
- Autoimmune disease
- Cardiovascular disease
- Respiratory disease
- Metabolic disease
Show all 9Show fewer
- Neurological signs
- Planned hip-replacement surgery within the next year
- Received exercise therapy within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- High-Dosage Exercise Therapy, Low-Dosage Exercise Therapy
- Keywords
- Exercise therapy
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dosage Exercise TherapyOther
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.)
Low-Dosage Exercise TherapyOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| High-dosage-group | Active comparator | Not described Receives: Other: High-Dosage Exercise Therapy |
| Low-dosage-group | Active comparator | Not described Receives: Other: Low-Dosage Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Index of Osteoarthritis (questionnaire)
WOMAC Index of Osteoarthritis (questionnaire)
Measured: 0 weeks, 8 weeks, 6 months postinterventional
Secondary outcomes (4)
HAD questionnaire
Measured: 0 weeks, 8 weeks, 6 months postinterventional
Tampa Scale for Kinesiophobia
Measured: 0 weeks, 8 weeks, 6 months postinterventional
Squats
Number of squats completed in 30 seconds.
Measured: 0 weeks, 8 weeks, 6 months postinterventional
Stairs
Time used to walk up and down 12 steps.
Measured: 0 weeks, 8 weeks, 6 months postinterventional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies 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
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Håvard Østerås, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700933
- Sponsor's protocol ID
- DROAPS1
- Status last verified
- Sep 2017
- First submitted
- 1 Oct 2012
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Osteras H, Paulsberg F, Olsen SE, Osteras B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.
PubMed 28532870
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study
- ClinicalTrials.gov ID
- NCT01700933
- Acronym / sponsor ID
- DROAPS1
- Conditions
- Osteoarthritis, Hip
- Keywords
- Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Oct 2012 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dosage-group | Active comparator | Other: High-Dosage Exercise Therapy |
| Low-dosage-group | Active comparator | Other: Low-Dosage Exercise Therapy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least three month since debut of the disease
- Age above 45 years
- Ability to complete the intervention
Key exclusion criteria (9 listed)
- Pain above 4 on VAS during gait
- Pregnancy
- Autoimmune disease
- Cardiovascular disease
- Respiratory disease
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 |
|---|---|---|
| High-Dosage Exercise TherapyStructure 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.) | Other | High-dosage-group |
| Low-Dosage Exercise TherapyStructure 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.) | Other | Low-dosage-group |
Primary outcome
WOMAC Index of Osteoarthritis (questionnaire)
Time frame: 0 weeks, 8 weeks, 6 months postinterventional
WOMAC Index of Osteoarthritis (questionnaire)
4 secondary outcomes
HAD questionnaire
Time frame: 0 weeks, 8 weeks, 6 months postinterventional
Tampa Scale for Kinesiophobia
Time frame: 0 weeks, 8 weeks, 6 months postinterventional
Squats
Time frame: 0 weeks, 8 weeks, 6 months postinterventional
Stairs
Time frame: 0 weeks, 8 weeks, 6 months postinterventional
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 21 Sep 2017.
- Results publication: PubMed 28532870Osteras H, Paulsberg F, Olsen SE, Osteras B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.
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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.
Håvard Østerås principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Dosage Exercise Therapy and Low-Dosage Exercise Therapy in people with Osteoarthritis, Hip, run by Norwegian University of Science and Technology 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 3 inclusion and 9 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 21 Sep 2017. 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?
WOMAC Index of Osteoarthritis (questionnaire) (time frame: 0 weeks, 8 weeks, 6 months postinterventional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01700933, which also lists 1 linked publication.
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 21 Sep 2017.