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Vascular Occlusion in Patients With Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training
Resistance training with vascular occlusion
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Sao Paulo -School of Medicine - Clinical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low intensity resistance training

High intensity resistance training

Low intensity resistance training with vascular occlusion

Arm Description

Outcomes

Primary Outcome Measures

muscle strength

Secondary Outcome Measures

Quality of Life

Full Information

First Posted
November 29, 2011
Last Updated
February 27, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01483131
Brief Title
Vascular Occlusion in Patients With Osteoarthritis
Official Title
Effects of Strength Training Associated With Vascular Occlusion in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low intensity resistance training
Arm Type
Experimental
Arm Title
High intensity resistance training
Arm Type
Experimental
Arm Title
Low intensity resistance training with vascular occlusion
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
12 weeks of resistance training twice a week.
Intervention Type
Other
Intervention Name(s)
Resistance training with vascular occlusion
Intervention Description
12 weeks of resistance training with vascular occlusion twice a week
Primary Outcome Measure Information:
Title
muscle strength
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Ferraz, Msc
Phone
55 11 8122 1203
Email
ferraz@email.com
Facility Information:
Facility Name
University of Sao Paulo -School of Medicine - Clinical Hospital
City
Sao Paulo
ZIP/Postal Code
05403 010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Ferraz, Msc
Phone
55 11 8122 1203
Email
ferraz@email.com
First Name & Middle Initial & Last Name & Degree
Hamilton Roschel, PhD
First Name & Middle Initial & Last Name & Degree
Ana Lucia Sá Pinto, PhD
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD

12. IPD Sharing Statement

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Vascular Occlusion in Patients With Osteoarthritis

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