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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03872869
Other study ID # 73/2005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2008
Est. completion date December 2009

Study information

Verified date March 2019
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- X-ray-verified hip OA, no walking aid and no joint replacements in the hips or knees.

Exclusion Criteria:

- no OA, joint replacement

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hip school or Tai CHi for arthritis
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lund University

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline, 6 month, 12 month
Secondary 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. Baseline, 6 month
Secondary 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. Baseline, 6 month
Secondary 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. Baseline, 6 month, 12 month
Secondary 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. Baseline 6 month, 12 month
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