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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00904319
Other study ID # 200903762
Secondary ID
Status Completed
Phase N/A
First received May 15, 2009
Last updated June 24, 2010
Start date April 2009
Est. completion date December 2009

Study information

Verified date June 2010
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The purpose of this research is to reduce disablement of older adults with symptomatic knee osteoarthritis.


Description:

Aquatic based training can offer many of the same benefits associated with a land based exercises but water has certain properties that provide a more gentle and welcoming environment for exercising. Buoyancy in water counteracts gravity to support the weight of the subject and decrease the forces put on the joints. Viscosity of water can provide resistance proportional to the effort exerted and with gentle friction enhancing proprioceptive feedback. Immersing in warm water can cause an increase in body temperature due to specific heat and thermal conductivity, which can cause blood vessels to dilate. In addition, hydrostatic forces reduce edema, increasing venous return and healthy circulation. [Prins, 1999]; [Wilder, 1998]

Studies have shown that water based exercise has been proven to significantly decrease pain in people with knee osteoarthritis compared to those in a land based exercise program. [Silva, 2003] In comparing an aquatic physical therapy session to a no intervention group the aquatic program resulted in less pain, improved physical function, quality of life, and strength. [Hinman, 2007]

The purpose of this research study is to determine whether an aquatic therapy program aimed at increasing muscle power will be effective in improving knee symptoms and mobility in men and women with symptomatic knee osteoarthritis.

The purpose of this study is to assess the efficacy of aquatic power training for improving mobility limitations, disability and quality of life in older adults with symptomatic knee OA.

Hypothesis 1: In older adults with symptomatic knee OA, a 6-week aquatic power training intervention will reduce lower limb mobility limitations (400m walk time).

Hypothesis 2: In comparison to baseline measures, at 6-week follow-up, there will be improvements in a) lower limb function (LLFDI), b) quality of life (KOOS Knee QOL),c) knee OA specific pain (KOOS pain) scores, and d) vastus lateralis muscle bulk (thigh muscle). These changes will be sustained at 12 week follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Age 50 or older

- Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by the American College of Rheumatology criteria and frequent knee symptoms)

Exclusion Criteria:

- bilateral knee replacement

- acute or terminal illness

- unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring use of supplement oxygen, or lower limb musculoskeletal surgery in the past 6 months

- unwilling to be in a pool (approximately 4 feet deep)

- 400m walk time equal to or slower than the median for sex and decade:

M 50's 250.2 60's 289.9 70's+ 290.8

F 50's 315.9 60's 305.2 70's+ 292.5

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Aquatic Power Training
Aquatic power training program with an exercise specialist 2/week for 6 weeks.

Locations

Country Name City State
United States The University of Iowa Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 400 meter walk time 0, 6, and 12 weeks No
Secondary Lower limb function (LLFDI) 0, 6, and 12 weeks No
Secondary Quality of life (KOOS) 0, 6, and 12 weeks No
Secondary Knee osteoarthritis pain (KOOS pain scores) 0 and 6 weeks No
Secondary Vastus lateralis muscle bulk 0, 2, 6, and 12 weeks No
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