Effectiveness of exercise therapy in hip osteoarthritis

ISRCTN	ISRCTN05601287
DOI	https://doi.org/10.1186/ISRCTN05601287
Protocol serial number	N/A
Sponsor	Mikkeli Central Hospital (Finland)
Funders	Mikkeli Central Hospital (Finland), Kuopio University Hospital (Finland), Kuopio University (Finland)

Submission date: 26/03/2009
Registration date: 07/04/2009
Last edited: 07/04/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jari Arokoski
Scientific

Department of Physical and Rehabilitation Medicine
Kuopio University Hospital and Institute of Clinical Medicine
Kuopio University
Kuopio
70211
Finland

Email	jari.arokoski@kuh.fi

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness of exercise therapy in hip osteoarthritis: a randomised controlled trial in primary health care
Study objectives	1. Patients with hip osteoarthritis (OA) can undergo an exercise-training programme despite their pain and disability 2. Strength and range of motion exercises and general aerobic conditioning can reduce hip pain and improve physical function more effectively than general treatment alone 3. Compliance of exercise therapy improves by using exercise diaries and leads to better long-term results 4. The exercise-training programme reduces the need of drug treatments and medical care of patients with hip OA more than general treatment alone
Ethics approval(s)	Ethics Committee of the Mikkeli Central Hospital approved on the 6th June 2005. Amendments approved on the 27th August 2007.
Health condition(s) or problem(s) studied	Osteoarthritis of the hip
Intervention	The intervention group received 12 supervised, (once per week, sustaining 45 minutes), rehabilitation sessions at baseline and four additional booster sessions at a point one year later. A physiotherapist working in primary care led supervised rehabilitation sessions for exercise groups consisting of ten participants at any given time. Following supervision, participants were recommended to perform the exercises using the same protocol three times per week for 3 years. The exercise programme was developed with common training principles as well as with the results of the other studies. It consisted of mainly strengthening exercises. The intensity of exercise training was not individually adjusted for each participant; they were recommended to perform strengthening exercise with maximum speed and power. Each training session started with a warm-up session with marching in place using arms as part of the movement for one minute. Stepping forward, backward, sideways in place for 2 minutes and finally cycling the legs in a supine position for 1 minute. The strengthening section included seven different exercises for hip and knee flexors, extensors, hip abductors and adductors and for pelvic and abdominal muscles for 30 - 35 minutes. The stretching section consisted of six different, analogues muscle flexibility exercises for hip, knee and ankle flexors and extensors and hip adductors, holding each position for 30 seconds with tailored intensity. Participants in the GP-care group (no intervention) received standard care.
Intervention type	Other
Primary outcome measure(s)	1. Self-reported pain and disease specific physical function were assessed by using the pain and functioning subscales of the WOMAC 2. Self-reported generic physical function was assessed by using the physical function score of the Finnish-validated SF-36 (36-item) Health Survey 3. Economic effectiveness was assessed by evaluating the number of doctor visits (associated with hip OA) and physiotherapy (sum score of using physiotherapy including exercise programme and/or inpatient rehabilitation associated with hip OA). The need of surgery (total hip replacement) and drug use (non-opioid analgesic (paracetamol, non steroidal anti-inflammatory drugs [NSAIDs]) and weak opioid (tramadol, codeine) concerning hip OA were also assessed. Assesssed at the following timepoints: 0, 3, 6, 12, 18, 24 and 36 months.
Key secondary outcome measure(s)	Objective functional scores: 1. Passive internal rotation and flexion of the hip joint 2. Extensor power of lower limb 3. Six Minute Walk Test (6MWT) 4. Ten-Metre Walk Test 5. Timed Up & Go (TUG) test 6. Sock Test Assessed at the following timepoints: 0, 3, 12, 24 and 36 months.
Completion date	07/04/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Both males and females, aged from 55 to 80 years 2. Unilateral or bilateral radiographic hip OA (X-ray less than 3 years old) 3. Pain experience in the hip region within the preceding month as indicated in the clinical criteria of the American College of Rheumatology
Key exclusion criteria	1. Total hip replacement 2. Rheumatoid arthritis 3. Cognitive impairment 4. Major surgical operation within the preceding 6 months in the lower limb or lower back area 5. Acute or sub-acute lower back pain 6. Cardiovascular or pulmonary disease or some other chronic disease that would prevent full participation in the training programme
Date of first enrolment	04/07/2005
Date of final enrolment	07/04/2009

Locations

Countries of recruitment

Finland

Study participating centre

Department of Physical and Rehabilitation Medicine

Kuopio
70211
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan