NCT00289458

Brief Summary

The objective of this project is to determine the effect of aquatic exercise and aquatic exercise combined with an education program on decreasing fall risk in older adults with hip osteoarthritis. The hypothesis is that aquatic exercise will improve function, strength and balance and the addition of the education session will enhance confidence in movement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 3, 2010

Completed
Last Updated

August 3, 2010

Status Verified

July 1, 2010

Enrollment Period

2.5 years

First QC Date

February 7, 2006

Results QC Date

February 13, 2009

Last Update Submit

July 6, 2010

Conditions

Keywords

older adults, falls, arthritis, aquatic, exercise

Outcome Measures

Primary Outcomes (5)

  • Change in Balance

    Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)

    baseline and 11 weeks

  • Change in Chair Stands

    change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)

    baseline and 11 weeks

  • Change in Walking

    change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks

    baseline and 11 weeks

  • Change in Falls-Efficacy

    change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)

    baseline and 11 weeks

  • Change in Dual Task Function

    change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)

    baseline and 11 weeks

Secondary Outcomes (1)

  • Change in Physical Activity

    baseline and 11 weeks

Study Arms (3)

Aquatic Education

EXPERIMENTAL

Exercise combined with education

Behavioral: 2

Aquatic

EXPERIMENTAL
Behavioral: exercise

Control

PLACEBO COMPARATOR
Behavioral: Control

Interventions

exerciseBEHAVIORAL

A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.

Aquatic
2BEHAVIORAL

Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk.

Aquatic Education
ControlBEHAVIORAL

no exercise

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • over age 65
  • clinical diagnosis of hip osteoarthritis

You may not qualify if:

  • medical condition tha significantly decreases functional ability such that not safe to exercise in a community program
  • already exercising in a moderate exercise program 2/week or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Kinesiology

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

ArthritisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Cathy M. Arnold
Organization
University of Saskatchewan

Study Officials

  • Cathy M Arnold, MSc

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 9, 2006

Study Start

October 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 3, 2010

Results First Posted

August 3, 2010

Record last verified: 2010-07

Locations