NCT00465660

Brief Summary

Female subjects over the age of 40 will be recruited and randomised into a progressive resistance training (PRT) or sham-exercise group. The PRT group will train at 80% of their peak strength, using Keiser pneumatic resistance machines, and progress approximately 3% per session. Strength will be re-assessed fortnightly. Exercises will target muscles around the hip and knee. The sham-exercise group will train on the same equipment as the PRT group except hip adduction, but without added resistance or progression. Both groups will train 3 days per week for roughly 45 minutes for 6 months. It is hypothesised that high intensity PRT will decelerate the tibial and femoral cartilage degeneration in the knee affected most by OA. Primary Outcome: Articular cartilage morphology following 6 months high intensity progressive resistance training Secondary Outcomes: Muscle and fat cross-sectional area (CSA) (pre and post) Muscle strength, power, endurance, and contraction velocity (pre, 3 months, \& post) Medications (pre, 3 months, \& post) Body composition (pre, 3 months, \& post) Balance; Physical function (pre, 3 months, \& post) Questionnaires (pre, 3 months, \& post)

  • Habitual exercise (PASE) -WOMAC index (pain, stiffness and functional ability)
  • Depressive symptoms (Depression Scale) -Quality of life (SF36)
  • Confidence performing physical activity (Ewart) -Demographics

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 25, 2007

Status Verified

December 1, 2006

First QC Date

April 24, 2007

Last Update Submit

April 24, 2007

Conditions

Keywords

OsteoarthritisCartilageExerciseProgressive Resistance Training

Outcome Measures

Primary Outcomes (1)

  • Articular cartilage morphology following 6 months high intensity progressive resistance training

Secondary Outcomes (12)

  • Muscle and fat cross-sectional area (CSA) (pre and post)

  • Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)

  • Medications (pre, 3 months, & post)

  • Body composition (pre, 3 months, & post)

  • Balance; Physical function (pre, 3 months, & post)

  • +7 more secondary outcomes

Interventions

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Aged over 40 years old
  • Primary Osteoarthritis in at least one knee using standard criteria of the American College of Rheumatology (ACR) criteria for classification of clinical osteoarthritis
  • Ambulatory without human assistance
  • Willingness to be randomised to experiential or control group
  • Ability to attend scheduled exercise and testing sessions

You may not qualify if:

  • Regular exercise of any kind over the past 3 months (\>1dpw).
  • Secondary osteoarthritis (traumatic or post-surgical), rheumatic disease, gouty or septic arthritis, Paget's disease, pseudogout, major congenital abnormalities, hemochromatosis, Wilson's disease and other rare forms of arthritis
  • Joint injury, injection or surgery within the past 6 months or knee joint replacement
  • Contraindications to MRI/Exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sydney

Sydney, New South Wales, 2140, Australia

Location

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Benedicte Vanwanseele, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 25, 2007

Study Start

April 1, 2005

Study Completion

July 1, 2009

Last Updated

April 25, 2007

Record last verified: 2006-12

Locations