Dose-response: Exercise Therapy on Hip Osteoarthritis

September 19, 2017 updated by: Norwegian University of Science and Technology

Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study

Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability. The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a well-documented effect on pain and function in patients with osteoarthritis of the hip. It is sought an optimal dose of exercise, in which this study will help to investigate.

We hypothesize that an exercise program designed to have a high number of repetitions will benefit the outcome of the training in a more positive way than a low-repetition based program.

Study Overview

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ørsta, Norway, 6154
        • Fysioterapitjenesten i Ørsta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least three month since debut of the disease
  • Age above 45 years
  • Ability to complete the intervention

Exclusion Criteria:

  • Pain above 4 on VAS during gait
  • Pregnancy
  • Autoimmune disease
  • Cardiovascular disease
  • Respiratory disease
  • Metabolic disease
  • Neurological signs
  • Planned hip-replacement surgery within the next year
  • Received exercise therapy within the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High-dosage-group

Structure of the exercise program done three times per week, for eight weeks:

5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)

Active Comparator: Low-dosage-group

Structure of the exercise program done three times per week, for eight weeks:

5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Index of Osteoarthritis (questionnaire)
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
WOMAC Index of Osteoarthritis (questionnaire)
0 weeks, 8 weeks, 6 months postinterventional

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HAD questionnaire
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
0 weeks, 8 weeks, 6 months postinterventional
Tampa Scale for Kinesiophobia
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
0 weeks, 8 weeks, 6 months postinterventional
Squats
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
Number of squats completed in 30 seconds.
0 weeks, 8 weeks, 6 months postinterventional
Stairs
Time Frame: 0 weeks, 8 weeks, 6 months postinterventional
Time used to walk up and down 12 steps.
0 weeks, 8 weeks, 6 months postinterventional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Håvard Østerås, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DROAPS1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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