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Dose-response: Exercise Therapy on Hip Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01700933
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Osteoarthritis, Hip Other: High-Dosage Exercise Therapy Other: Low-Dosage Exercise Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study
Actual Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
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.)


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


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

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


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
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
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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
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Publications of Results:

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01700933     History of Changes
Other Study ID Numbers: DROAPS1
First Posted: October 4, 2012    Key Record Dates
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