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Dose-response: Exercise Therapy on Hip Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01700933
First received: October 1, 2012
Last updated: March 22, 2016
Last verified: March 2016
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    WOMAC Index of Osteoarthritis (questionnaire)


Secondary Outcome Measures:
  • HAD questionnaire [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ] [ Designated as safety issue: No ]
  • Tampa Scale for Kinesiophobia [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ] [ Designated as safety issue: No ]
  • Squats [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ] [ Designated as safety issue: No ]
    Number of squats completed in 30 seconds.

  • Stairs [ Time Frame: 0 weeks, 8 weeks, 6 months postinterventional ] [ Designated as safety issue: No ]
    Time used to walk up and down 12 steps.
Enrollment: 35
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
Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01700933     History of Changes
Other Study ID Numbers: DROAPS1 
Study First Received: October 1, 2012
Last Updated: March 22, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on September 30, 2016