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
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
-
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.