Condition category
Musculoskeletal Diseases
Date applied
31/10/2008
Date assigned
23/01/2009
Last edited
16/07/2010
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 Tapani Pöyhönen

ORCID ID

Contact details

Kymenlaakso Central Hospital
Kotkantie 41
Kotka
48210
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of progressive aquatic resistance training on mobility limitation and lower leg impairments after unilateral knee replacement

Acronym

Study hypothesis

Progressive aquatic resistance training improves mobility ability, muscle power and mass after knee replacement.

Ethics approval

The Ethical Committee of the Kymenlaakso Central Hospital gave approval on the 16th February 2004

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Knee joint osteoarthritis

Intervention

The 12 week aquatic exercise was specifically directed to improve quadriceps and hamstring muscle strength, power and muscle mass, and thus mobility. The control group did not receive any intervention. Participants were encouraged to continue their lives as usual and maintain their level of physical activity during the trial. Sessions were conducted twice a week in small classes including 4 - 5 people. Measurements were performed before and after the 12 week training period for both study groups.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Physical functional and mobility difficulties were assessed by Western Ontario and McMaster Universities osteoarthritis index (WOMAC) questionnaire, and mobility limitation by 10-metre habitual walking speed and stair ascending time. Measured 2 - 3 days before and after the 12 weeks training period both in exercise and control groups.

Secondary outcome measures

Knee extensor (KEP) and flexor power (KFP) were assessed isokinetically, and thigh muscle cross-sectional area (LCSA) by computed tomography (CT). Measured 2 - 3 days before and after the 12 weeks training period both in exercise and control groups.

Overall trial start date

01/01/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All 201 patients (women and men, aged 55 - 75 years) who, according to the physical therapy records of Kymenlaakso Central Hospital, had undergone unilateral knee replacement 4 - 18 months prior to the study were informed about the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

201

Participant exclusion criteria

1. Bilateral knee arthroplasty
2. Revision arthroplasty
3. Severe cardiovascular diseases
4. Dementia
5. Rheumatoid arthritis
6. Any major operation in either of the knees

Recruitment start date

01/01/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Finland

Trial participating centre

Kymenlaakso Central Hospital
Kotka
48210
Finland

Sponsor information

Organisation

Kymenlaakso Central Hospital (Finland)

Sponsor details

Kotkantie 41
Kotka
Fin-48210
Finland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Kymenlaakso Central Hospital (Finland) - research funding

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20510971

Publication citations

  1. Results

    Valtonen A, Pöyhönen T, Sipilä S, Heinonen A, Effects of aquatic resistance training on mobility limitation and lower-limb impairments after knee replacement., Arch Phys Med Rehabil, 2010, 91, 6, 833-839, doi: 10.1016/j.apmr.2010.03.002.

Additional files

Editorial Notes