- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483131
Vascular Occlusion in Patients With Osteoarthritis
February 27, 2014 updated by: Bruno Gualano, University of Sao Paulo
Effects of Strength Training Associated With Vascular Occlusion in Patients With Knee Osteoarthritis
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass than resistance training alone.
The investigators speculate this training strategy could be beneficial in patients with osteoarthritis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sao Paulo, Brazil, 05403 010
- Recruiting
- University of Sao Paulo -School of Medicine - Clinical Hospital
-
Contact:
- Rodrigo Ferraz, Msc
- Phone Number: 55 11 8122 1203
- Email: ferraz@email.com
-
Principal Investigator:
- Hamilton Roschel, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Postmenopausal women
- BMI <39
- Knee Ostearthritis type II and III
- VAS (visual analogue scale) between 2 and 8
Exclusion Criteria:
- Hip osteoarthritis
- Use of NSAID
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low intensity resistance training
|
12 weeks of resistance training twice a week.
|
|
Experimental: High intensity resistance training
|
12 weeks of resistance training twice a week.
|
|
Experimental: Low intensity resistance training with vascular occlusion
|
12 weeks of resistance training with vascular occlusion twice a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
muscle strength
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Life
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
November 29, 2011
First Submitted That Met QC Criteria
November 30, 2011
First Posted (Estimate)
December 1, 2011
Study Record Updates
Last Update Posted (Estimate)
February 28, 2014
Last Update Submitted That Met QC Criteria
February 27, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- vascular occlusion and OA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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