Dose-response: Exercise Therapy on Hip Osteoarthritis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Østerås H, Paulsberg F, Olsen SE, Østerås B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.

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
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