Condition category
Musculoskeletal Diseases
Date applied
02/02/2016
Date assigned
08/02/2016
Last edited
11/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteoarthritis (OA) is the most common type of arthritis and affects millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, causing stiffness, pain and a reduction in the range of movement. The knee is the most common joint to be affected by OA and in many sufferers, the pain prevents people from moving around leading to muscle weakness and disability. Exercise is considered to be an important part of treatment for knee OA, however when the condition is particularly severe it is difficult to find effective training methods that do not cause the sufferer too much pain. Aquatic resistance training is a type of exercise where a person completes low-impact exercise, such as walking, through water. The natural resistance provided by the water helps to strengthen muscles without putting pressure on the bones and joints. The aim of this study is to find out whether aquatic resistance training can help to strengthen muscles and reduce knee symptoms such as pain and stiffness, in patients suffering from knee OA.

Who can participate?
Adults aged between 50 and 75 with severe OA who have had continuous knee pain for at least 6 months.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in a 12 week course of aquatic resistance training. The training takes place twice a week in a hospital pool and is experienced by a trained physiotherapist. In the sessions participants where resistance boots (special boots designed to increase resistance) and complete low-impact exercises such as walking through the water. Those in the second group continue to receive standard care and do not take part in any extra training. At the start of the study and then again after 6 and 8 months, participants in both groups complete a number of questionnaires and physical tests in order to assess their muscle strength and knee symptoms.

What are the possible benefits and risks of participating?
All participants benefit from receiving information about their physical performance. Participants who are in the training group may benefit from improved muscle power and decreased knee symptoms. Risks of taking part are minor but some participants may experience temporary muscle pain after training.

Where is the study run from?
Kymenlaakso Central Hospital (Finland)

When is the study starting and how long is it expected to run for?
November 2002 to April 2004

Who is funding the study?
Kymenlaakso Central Hospital Research Fund (Finland)

Who is the main contact?
Dr Anu Valtonen

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anu Valtonen

ORCID ID

Contact details

Metropolia University of Applied Sciences
Department of human movement and functioning
Helsinki
FIN-00079
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Preoperative aquatic resistance training program to increase muscle power and decrease knee symptoms in persons with knee osteoarthritis: A randomized controlled trial

Acronym

ARISTO

Study hypothesis

Twelve week preoperative aquatic resistance training intervention will increase muscle power and decrease knee symptoms in persons with end-stage knee osteoarthritis compared to controls receiving standard care.

Ethics approval

Ethical committee of Kymenlaakso Central Hospital, 21/02/2005, ref: 2/2005/23.2.05

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Knee osteoarthritis

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants receive a 12-week progressive aquatic resistance training intervention that aims to decrease knee symptoms and increase muscle power. Group-based training is conducted in hospital pool and supervised by physiotherapist.

Control group: Participants receive the standard preoperative care, which includes written instructions for training.

Total duration of both preoperative study arms is 12 weeks. Participants are followed up from six to eight months postsurgery.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Muscle power is measured using isokinetic device at baseline, 12 weeks and 6 to 8 months postsurgery
2. Knee symptoms are measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline, 12 weeks and 6 to 8 months postsurgery

Secondary outcome measures

1. Muscle torque is measured using isokinetic device at baseline, 12 weeks and 6 to 8 months postsurgery
2. Thigh muscle cross-sectional area is measured using computed tomography at baseline, 12 weeks and 6 to 8 months postsurgery
3. Walking speed is measured using maximal 10 meter walk test at baseline, 12 weeks and 6 to 8 months postsurgery
4. Ability negotiating stairs is assessed by measured stair ascending and descending times at baseline, 12 weeks and 6 to 8 months postsurgery
5. Mobility and balance is measured using the 8-figure-run test at baseline, 12 weeks and 6 to 8 months postsurgery
6. Ability to get up from the chair is measured using the sit-to-stand test at baseline, 12 weeks and 6 to 8 months postsurgery
7. Mobility and balance is measured using the timed up and go test (TUG) at baseline, 12 weeks and 6 to 8 months postsurgery
8. Quality of life is measured using RAND 36-item health survey 1.0 at baseline, 12 weeks and 6 to 8 months postsurgery

Overall trial start date

01/01/2009

Overall trial end date

10/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 50 and 75 years
2. Medial knee osteoarthritis according a radiographic grading of Kellgren/Lawrence (K/L) K/L 3 or K/L 4
3. Continuous knee pain lasting at least 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Lateral knee osteoarthritis
2. Patellofemoral osteoarthritis
3. Rheumatoides arthritis
4. Post-traumatic arthritis
5. Earlier osteotomy
6. Severe cardiovascular disease
7. Dementia
8. Urinary incontinence

Recruitment start date

01/05/2008

Recruitment end date

31/01/2013

Locations

Countries of recruitment

Finland

Trial participating centre

Kymenlaakso Central Hospital
Kotkantie 41
Kotka
FIN-48210
Finland

Sponsor information

Organisation

University of Jyväskylä

Sponsor details

Department of health sciences
PO Box 35
Jyväskylä
FIN-40014
Finland

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Kymenlaakso Central Hospital Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of randomised controlled trial with postoperative followup are planned to be published in a peer reviewed journal.

Intention to publish date

30/11/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes