Condition category
Musculoskeletal Diseases
Date applied
26/03/2009
Date assigned
07/04/2009
Last edited
07/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jari Arokoski

ORCID ID

Contact details

Department of Physical and Rehabilitation Medicine
Kuopio University Hospital and Institute of Clinical Medicine
Kuopio University
Kuopio
70211
Finland
jari.arokoski@kuh.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of exercise therapy in hip osteoarthritis: a randomised controlled trial in primary health care

Acronym

Study hypothesis

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

Ethics Committee of the Mikkeli Central Hospital approved on the 6th June 2005. Amendments approved on the 27th August 2007.

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

04/07/2005

Overall trial end date

07/04/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

04/07/2005

Recruitment end date

07/04/2009

Locations

Countries of recruitment

Finland

Trial participating centre

Department of Physical and Rehabilitation Medicine
Kuopio
70211
Finland

Sponsor information

Organisation

Mikkeli Central Hospital (Finland)

Sponsor details

Porrassalmenkatu 35-37
Mikkeli
50100
Finland
riikka.juhakoski@esshp.fi

Sponsor type

Hospital/treatment centre

Website

http://www.esshp.fi/

Funders

Funder type

Hospital/treatment centre

Funder name

Mikkeli Central Hospital (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Kuopio University Hospital (Finland)

Alternative name(s)

Kuopio University Hospital, KYS

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Finland

Funder name

Kuopio University (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes