Osteoarthritis, HipNCT01253798
Group Exercise After Hip Replacement Surgery
A study testing Group training in people with Osteoarthritis, Hip, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine which group exercise one should choose when hip osteoarthritis patients have undergone hip replacement surgery. To determine this, we want to answer the following research question: Are there differences in function and muscle strength in osteoarthritis patients who conduct… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Group training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2010to Jan 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hip osteoarthritis patients who undergo surgery with total prosthesis at St. Olav's Hospital, Department Orkdal.
- Participants must live in commuting distance from the hospital, as the training is organized as outpatient training
- Participants must be able to take instruction and master the Norwegian language
Who cannot join
- Patients who experience serious complications after surgery
- if a person has a disease that causes that one can not complete the planned training
Trial locations and contacts
1 site in 1 country.
Norway1 site
St. Olavs Hospital, department Orkdal
Orkanger, Sør-Trøndelag, 7030
About this study
Official title: What Type of Group Exercise Should be Chosen for Osteoarthritis Patients in the Rehabilitation Phase Following Hip Replacement Surgery?
The purpose of this study is to determine which group exercise one should choose when hip osteoarthritis patients have undergone hip replacement surgery. To determine this, we want to answer the following research question:
Are there differences in function and muscle strength in osteoarthritis patients who conduct group training either on land or in water in the rehabilitation phase following hip replacement surgery?
- Conditions
- Osteoarthritis, Hip
- Being tested
- Group training
- Keywords
- exercise, hydrotherapy
- 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.
Group trainingOther
Each session lasts 50 minutes and consists of warm-up, mobility training, strength training, balance training and endurance training. Mobility training is conducted to increase range of motion in the operated hip, strength exercises are conducted to strengthen muscles around the operated hip, balance training are conducted to improve stability around the operated hip and endurance training are conducted to increase patients' physical capacity. This is in line with current guidelines for the exercise of osteoarthritis patients.
| Study group | Role | What they receive |
|---|---|---|
| Group training on land | Active comparator | Group training in water and on land are carried out by the same principles, which is to improve general function, and to improve function and strength around the operated hip. Receives: Other: Group training |
| Group training in water | Active comparator | Group training in water and on land are carried out by the same principles, which is to improve general function, and to improve function and strength around the operated hip Receives: Other: Group training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function1
Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).
Measured: Pre-operative
Function2
Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).
Measured: Post-operative
Funtion3
Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).
Measured: After 12 weeks training
Secondary outcomes (3)
Muscle strength1
Muscle strength around the operated hip are evaluated by measuring isometric muscle strength in hip-abduction and knee-extension using a hand-held dynamometer (HHD) from Lafayette Instruments.
Measured: Pre-operative
Muscle strength2
Muscle strength around the operated hip are evaluated by measuring isometric muscle strength in hip-abduction and knee-extension using a hand-held dynamometer (HHD) from Lafayette Instruments.
Measured: Post-operative
Muscle strength3
Muscle strength around the operated hip are evaluated by measuring isometric muscle strength in hip-abduction and knee-extension using a hand-held dynamometer (HHD) from Lafayette Instruments.
Measured: After 12 weeks training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: recruitement unsuccessful
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ottar Vasseljen, Principal investigator, NTNU, Medisink fakultet, Institutt for samfunnsmedisin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253798
- Sponsor's protocol ID
- NTNU-ISM-KH-2010
- Status last verified
- Sep 2012
- First submitted
- 2 Dec 2010
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Type of Group Exercise Should be Chosen for Osteoarthritis Patients in the Rehabilitation Phase Following Hip Replacement Surgery?
- ClinicalTrials.gov ID
- NCT01253798
- Acronym / sponsor ID
- NTNU-ISM-KH-2010
- Conditions
- Osteoarthritis, Hip
- Keywords
- exercise, hydrotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitement unsuccessful
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Dec 2010 (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.
The purpose of this study is to determine which group exercise one should choose when hip osteoarthritis patients have undergone hip replacement surgery. To determine this, we want to answer the following research question:
Are there differences in function and muscle strength in osteoarthritis patients who conduct group training either on land or in water in the rehabilitation phase following hip replacement surgery?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group training on land | Active comparator | Other: Group trainingGroup training in water and on land are carried out by the same principles, which is to improve general function, and to improve function and strength around the operated hip. |
| Group training in water | Active comparator | Other: Group trainingGroup training in water and on land are carried out by the same principles, which is to improve general function, and to improve function and strength around the operated hip |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hip osteoarthritis patients who undergo surgery with total prosthesis at St. Olav's Hospital, Department Orkdal.
- Participants must live in commuting distance from the hospital, as the training is organized as outpatient training
- Participants must be able to take instruction and master the Norwegian language
Key exclusion criteria (2 listed)
- Patients who experience serious complications after surgery
- if a person has a disease that causes that one can not complete the planned training
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 |
|---|---|---|
| Group trainingEach session lasts 50 minutes and consists of warm-up, mobility training, strength training, balance training and endurance training. Mobility training is conducted to increase range of motion in the operated hip, strength exercises are conducted to strengthen muscles around the operated hip, balance training are conducted to improve stability around the operated hip and endurance training are conducted to increase patients' physical capacity. This is in line with current guidelines for the exercise of osteoarthritis patients. | Other | Group training in water, Group training on land |
Primary outcome
Function1
Time frame: Pre-operative
Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).
Function2
Time frame: Post-operative
Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).
Funtion3
Time frame: After 12 weeks training
Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).
3 secondary outcomes
Muscle strength1
Time frame: Pre-operative
Muscle strength2
Time frame: Post-operative
Muscle strength3
Time frame: After 12 weeks training
Results and safety
The study was stopped early (reason given: recruitement unsuccessful). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
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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.
Ottar Vasseljen principal investigator
NTNU, Medisink fakultet, Institutt for samfunnsmedisin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group training 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 2 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: stopped early, as of the sponsor's last update on 20 Sep 2012. 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 was stopped early (reason given: recruitement unsuccessful). Results are not available in the source record.
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?
Function1 (time frame: Pre-operative). The study lists 3 primary outcomes in all. 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 20 Sep 2012.