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Dose-response: Exercise Therapy on Hip Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700933
First Posted: October 4, 2012
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose

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.


Condition Intervention
Osteoarthritis, Hip Other: High-Dosage Exercise Therapy Other: Low-Dosage Exercise Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • WOMAC Index of Osteoarthritis (questionnaire) [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ]
    WOMAC Index of Osteoarthritis (questionnaire)


Secondary Outcome Measures:
  • HAD questionnaire [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ]
  • Tampa Scale for Kinesiophobia [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ]
  • Squats [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ]
    Number of squats completed in 30 seconds.

  • Stairs [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ]
    Time used to walk up and down 12 steps.


Enrollment: 35
Actual Study Start Date: September 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High-dosage-group Other: High-Dosage Exercise Therapy

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 Other: Low-Dosage Exercise Therapy

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.)


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700933


Locations
Norway
Fysioterapitjenesten i Ørsta
Ørsta, Norway, 6154
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Håvard Østerås Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01700933     History of Changes
Other Study ID Numbers: DROAPS1
First Submitted: October 1, 2012
First Posted: October 4, 2012
Last Update Posted: September 21, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Exercise therapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases