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Completed

NCT Number: NCT03872869

Tai Chi and Hip School for Patients With Hip-OA.

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip school or Tai CHi for arthritis

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in The Body Awareness Scale Movement Quality (BAS MQ)

    Time frame: Baseline, 6 month

    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.

  2. Change in The Six Minute Walk Test (6MWT).

    Time frame: Baseline, 6 month

    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.

  3. Change in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)

    Time frame: Baseline, 6 month, 12 month

    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.

  4. Change in The Arthritis Self-Efficacy Scale (ASES)

    Time frame: Baseline 6 month, 12 month

    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.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Tai Chi and Hip School for Patients With Hip-OA: a Randomized Controlled Trial With a 6 - and 12 Months Follow-up

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 13, 2019
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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