NCT03872869

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

February 25, 2019

Last Update Submit

March 11, 2019

Conditions

Keywords

osteoarthritispatient educationTai Chiphysical function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    Baseline, 6 month

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

    Baseline, 6 month

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

    Baseline, 6 month, 12 month

  • Change in The Arthritis Self-Efficacy Scale (ASES)

    Baseline 6 month, 12 month

Study Arms (3)

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.

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.

Other: Hip school or Tai CHi for arthritis

Control group

NO INTERVENTION

Interventions

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

Hip SchoolTai Chi for arthritis (TCA)

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • no OA, joint replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Anne Sundén, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigators did not know which group the patients had been assigned to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RPT, PhD, Lecturer

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 13, 2019

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Individual participant data has not been shared with other researchers