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Vascular Occlusion and Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

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

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female with rheumatoid arthritis
  • Disease activity scores > 2.6
  • use of anti-TNF-alpha drugs for at least 8 weeks

Exclusion Criteria:

  • BMD < 20 kg/m2
  • fibromyalgia
  • cardiovascular disease

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

No Intervention

Arm Label

low intensity with vascular occlusion

high intensity resistance training

no exercise training

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
NCT01483157
Brief Title
Vascular Occlusion and Rheumatoid Arthritis
Official Title
Effects of Strength Training With Vascular Occlusion in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial
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 2015 (Anticipated)
Study Completion Date
November 2015 (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 resistance training alone. The investigators speculate this training strategy could be beneficial in patients with rheumatoid arthritis.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
low intensity with vascular occlusion
Arm Type
Experimental
Arm Title
high intensity resistance training
Arm Type
Experimental
Arm Title
no exercise training
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
vascular occlusion with exercise trainig
Intervention Description
twelve weeks of resistance training with vascular occlusion twice a week
Intervention Type
Other
Intervention Name(s)
high intensity resistance training
Intervention Description
twelve weeks of resistance training twice a week
Primary Outcome Measure Information:
Title
muscle strength
Time Frame
twelve weeks
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
twelve weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female with rheumatoid arthritis Disease activity scores > 2.6 use of anti-TNF-alpha drugs for at least 8 weeks Exclusion Criteria: BMD < 20 kg/m2 fibromyalgia cardiovascular disease
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
Reynaldo Costa Rodrigues, PhD Student
Phone
55 11 26618022
Email
rcrodriguespt@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Ana Lucia Sa Pinto, PhD
First Name & Middle Initial & Last Name & Degree
Lissiane Noronha Guedes, MD
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31033228
Citation
Rodrigues R, Ferraz RB, Kurimori CO, Guedes LK, Lima FR, de Sa-Pinto AL, Gualano B, Roschel H. Low-Load Resistance Training With Blood-Flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2020 Jun;72(6):787-797. doi: 10.1002/acr.23911. Epub 2020 May 14.
Results Reference
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Vascular Occlusion and Rheumatoid Arthritis

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