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: January 27, 2017

Last verified: January 2017

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 Intervention Model: Parallel Assignment Masking: Participant Primary Purpose: Treatment
Official Title:	Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Osteoarthritis

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 ]
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
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.)

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)
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

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:	January 27, 2017

Additional relevant MeSH terms:


Osteoarthritis Osteoarthritis, Hip Arthritis	Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on May 24, 2017

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