OsteoarthritisNCT03872869
Tai Chi and Hip School for Patients With Hip-OA.
A study testing Hip school or Tai CHi for arthritis in people with Osteoarthritis, run by Lund University.
Trial summary
A randomized, controlled study was conducted in southern Sweden with two intervention programs for individuals with X-ray-verified hip osteoarthritis (OA). The patients were randomized to 1 of 3 groups; namely Hip School, Tai Chi for Arthritis (TCA), or a group receiving no intervention. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hip school or Tai CHi for arthritis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2009
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- X-ray-verified hip OA, no walking aid and no joint replacements in the hips or knees.
Who cannot join
- no OA, joint replacement
About this study
Official title: Tai Chi and Hip School for Patients With Hip-OA: a Randomized Controlled Trial With a 6 - and 12 Months Follow-up
A randomized, controlled study was conducted in southern Sweden with two intervention programs for individuals with X-ray-verified hip osteoarthritis (OA). The patients were randomized to 1 of 3 groups; namely Hip School, Tai Chi for Arthritis (TCA), or a group receiving no intervention. The results showed significant improvement in physical function and self-efficacy within the interventions groups Tai Chi and Hip School. The Tai Chi group showed improvement in body awareness and quality of movements, and in self-efficacy between baseline and 6- month follow-up. The Hip School group showed significant improvement in body awareness and quality of movements between baseline and 6-month follow-up.
Read the detailed description
A randomized, controlled study was conducted in southern Sweden with two intervention programs for individuals with X-ray-verified hip OA. The patients were randomized to 1 of 3 groups; namely Hip School, TCA, or a group receiving no intervention. A total of 89 subjects attended the baseline appointment and were randomized to one of the three groups. Physical function was assessed using, the Hip Osteoarthritis Outcomes Score (HOOS, Swedish version L.K 1.1), an observational assessment of movements the Body Awareness Scale Movement Quality (BAS MQ) and the Six Minute Walk Test (6MWT). For assessment of HRQL the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used. The Arthritis Self-Efficacy Scale (ASES) records the patient's self-reported judgment of what he/she can do regardless of the degree of functional limitations or skill. Six months after the final intervention all subjects were examined and assessed following the same procedure as at baseline. The 12 months follow-up contained the three questionnaires, HOOS, ASES and SF- 36 were sent out by mail. The results showed significant improvement in physical function and self-efficacy within the interventions groups Tai Chi and Hip School. The Tai Chi showed improvement in BAS MQ, focusing on body awareness and quality of movements, and in self-efficacy between baseline and 6- month follow-up. The Hip School group showed significant improvement in BAS MQ between baseline and 6-month follow-up.
- Conditions
- Osteoarthritis
- Being tested
- Hip school or Tai CHi for arthritis
- Keywords
- osteoarthritis, patient education, Tai Chi, physical function
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip school or Tai CHi for arthritisOther
Eighty-nine individuals were randomized to one of the three intervention groups 30 individuals to Tai Chi,30 individuals to Hip School and 29 individuals to the control group
| Study group | Role | What they receive |
|---|---|---|
| Hip School | Active comparator | The participants in the Hip School were required to attend three 1.5 hour classes which were conducted by specially trained physiotherapists in premise at Lund University. Receives: Other: Hip school or Tai CHi for arthritis |
| Tai Chi for arthritis (TCA) | Active comparator | The treatment intervention with TCA was scheduled in a group setting. Class size for Tai Chi groups was 8- 10 individuals. The group was led by a physiotherapist, specially trained in the concept, in premise at Lund University. The participants in the Tai Chi group were required to attend classes for 12-16 one- hour sessions, twice a week for the first four weeks and then once a week. Receives: Other: Hip school or Tai CHi for arthritis |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hip Osteoarthritis Outcomes Score (HOOS, Swedish version L.K 1.1)
An instrument for assessing patients' options and limitations associated with their hip problems. The questionnaire consists of 39 items in 5 subscales, pain (P, 9 items), other symptoms including stiffness (S, 5 items), activity limitations daily living (ADL, 17 items), activity limitations recreation and sport (SP, 4 items) and hip-related quality of life (QOL, 4 items).
Measured: Baseline, 6 month, 12 month
Secondary outcomes (4)
Change in The Body Awareness Scale Movement Quality (BAS MQ)
A physiotherapeutic assessment focusing on body awareness and quality of movements, including quality of everyday functional movements and movement behavior, assessed through observation from a structured movement test.
Measured: Baseline, 6 month
Change in The Six Minute Walk Test (6MWT).
Timed walking tests are used to evaluate functional exercise performance and measure the ability to carry-out the activities of daily life. The total distance in meters covered in 6 minutes was recorded.
Measured: Baseline, 6 month
Change in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Assessment of HRQL. SF-36 has two summary scales: a Physical Component Scale, PCS, with four subscales: physical functioning (PF, 10 items), role limitation owing to physical health problems (RP, 4 items), bodily pain (BP, 2 items), general health perception (GH, 5 items) as well as a Mental Component Scale, MCS, with four subscales: vitality (VT, 4 items), social functioning (SF, 2 items), role limitation owing to emotional problems (RE, 3 items) and mental health (MH, 5 items). The scores on all subscales range from 0 to 100, with higher scores indicating better health states.
Measured: Baseline, 6 month, 12 month
Change in The Arthritis Self-Efficacy Scale (ASES)
Patient's self-reported judgment of what he/she can do regardless of the degree of functional limitations or skill. The ASES consist of 20 items (3 subscales and a total score) which measures: a person's perceived ability to control pain (SEP, 5 items), self-efficacy to perform functions in daily living (SEF, 9 items) and the self-efficacy to control other symptoms related to chronic disease (SEOS, 6 items). Each item ranges from 10=very uncertain to 100=very certain to accomplish the described task. Each subscale is scored by calculating the mean of the items. A higher score indicates better self-efficacy.
Measured: Baseline 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Model description
- After an advertisement in a local paper, over 300 volunteers applied to participate in the study. All 300 received information about the study by mail or telephone. One hundred volunteers fulfilled the inclusion criteria: X-ray-verified hip OA, 40-75 years of age, no walking aid and no joint replacements in the hips or knees. Each individual had to specify at which hospital and when they had been X-rayed and/or received their diagnosis. A total of 89 subjects attended the baseline appointment and were randomized to one of the three groups. The randomization procedure, in blocks of 15, was generated by a computer-based system
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Sunden, Lund University
- Investigators
- Anne Sundén, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872869
- Sponsor's protocol ID
- 73/2005
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data has not been shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi and Hip School for Patients With Hip-OA: a Randomized Controlled Trial With a 6 - and 12 Months Follow-up
- ClinicalTrials.gov ID
- NCT03872869
- Acronym / sponsor ID
- 73/2005
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, patient education, Tai Chi, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Mar 2019 (actual)
- 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.
A randomized, controlled study was conducted in southern Sweden with two intervention programs for individuals with X-ray-verified hip osteoarthritis (OA). The patients were randomized to 1 of 3 groups; namely Hip School, Tai Chi for Arthritis (TCA), or a group receiving no intervention. The results showed significant improvement in physical function and self-efficacy within the interventions groups Tai Chi and Hip School. The Tai Chi group showed improvement in body awareness and quality of movements, and in self-efficacy between baseline and 6- month follow-up. The Hip School group showed significant improvement in body awareness and quality of movements between baseline and 6-month follow-up.
Detailed description
A randomized, controlled study was conducted in southern Sweden with two intervention programs for individuals with X-ray-verified hip OA. The patients were randomized to 1 of 3 groups; namely Hip School, TCA, or a group receiving no intervention. A total of 89 subjects attended the baseline appointment and were randomized to one of the three groups. Physical function was assessed using, the Hip Osteoarthritis Outcomes Score (HOOS, Swedish version L.K 1.1), an observational assessment of movements the Body Awareness Scale Movement Quality (BAS MQ) and the Six Minute Walk Test (6MWT). For assessment of HRQL the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used. The Arthritis Self-Efficacy Scale (ASES) records the patient's self-reported judgment of what he/she can do regardless of the degree of functional limitations or skill. Six months after the final intervention all subjects were examined and assessed following the same procedure as at baseline. The 12 months follow-up contained the three questionnaires, HOOS, ASES and SF- 36 were sent out by mail. The results showed significant improvement in physical function and self-efficacy within the interventions groups Tai Chi and Hip School. The Tai Chi showed improvement in BAS MQ, focusing on body awareness and quality of movements, and in self-efficacy between baseline and 6- month follow-up. The Hip School group showed significant improvement in BAS MQ between baseline and 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- After an advertisement in a local paper, over 300 volunteers applied to participate in the study. All 300 received information about the study by mail or telephone. One hundred volunteers fulfilled the inclusion criteria: X-ray-verified hip OA, 40-75 years of age, no walking aid and no joint replacements in the hips or knees. Each individual had to specify at which hospital and when they had been X-rayed and/or received their diagnosis. A total of 89 subjects attended the baseline appointment and were randomized to one of the three groups. The randomization procedure, in blocks of 15, was generated by a computer-based system
| Arm | Type | Receives |
|---|---|---|
| Hip School | Active comparator | Other: Hip school or Tai CHi for arthritisThe participants in the Hip School were required to attend three 1.5 hour classes which were conducted by specially trained physiotherapists in premise at Lund University. |
| Tai Chi for arthritis (TCA) | Active comparator | Other: Hip school or Tai CHi for arthritisThe treatment intervention with TCA was scheduled in a group setting. Class size for Tai Chi groups was 8- 10 individuals. The group was led by a physiotherapist, specially trained in the concept, in premise at Lund University. The participants in the Tai Chi group were required to attend classes for 12-16 one- hour sessions, twice a week for the first four weeks and then once a week. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- X-ray-verified hip OA, no walking aid and no joint replacements in the hips or knees.
Key exclusion criteria (1 listed)
- no OA, joint replacement
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 |
|---|---|---|
| Hip school or Tai CHi for arthritisEighty-nine individuals were randomized to one of the three intervention groups 30 individuals to Tai Chi,30 individuals to Hip School and 29 individuals to the control group | Other | Hip School, Tai Chi for arthritis (TCA) |
Primary outcome
Change in Hip Osteoarthritis Outcomes Score (HOOS, Swedish version L.K 1.1)
Time frame: Baseline, 6 month, 12 month
An instrument for assessing patients' options and limitations associated with their hip problems. The questionnaire consists of 39 items in 5 subscales, pain (P, 9 items), other symptoms including stiffness (S, 5 items), activity limitations daily living (ADL, 17 items), activity limitations recreation and sport (SP, 4 items) and hip-related quality of life (QOL, 4 items).
4 secondary outcomes
Change in The Body Awareness Scale Movement Quality (BAS MQ)
Time frame: Baseline, 6 month
Change in The Six Minute Walk Test (6MWT).
Time frame: Baseline, 6 month
Change in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline, 6 month, 12 month
Change in The Arthritis Self-Efficacy Scale (ASES)
Time frame: Baseline 6 month, 12 month
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 13 Mar 2019.
- Individual participant dataSharing planned: No. Individual participant data has not been shared with other researchers
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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.
Anne Sundén, PhD principal investigator
Lund University
Questions about this trial
What is this clinical trial studying?
A study testing Hip school or Tai CHi for arthritis in people with Osteoarthritis, run by Lund University.
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 1 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 in Hip Osteoarthritis Outcomes Score (HOOS, Swedish version L.K 1.1) (time frame: Baseline, 6 month, 12 month). 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 13 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.