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The Effects Of Low Intensity Training With Blood Flow Restriction In Rheumatoid Arthritis Patients (TBFR)

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High intensity resistance training
Low intensity resistance training combined with blood flow restriction
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Kaatsu, Blood Flow Restriction Training

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female; Rheumatoid arthritis patients; All individuals will undergo an ergospirometry to ensure cardiorespiratory conditions. Exclusion Criteria: Fibromyalgia; Cardiovascular disease;

Sites / Locations

  • Universidade Federal do Rio Grande do Sul - Faculdade de Medicina - Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High intensity resistance training

Low intensity resistance training combined with blood flow restriction

Arm Description

Outcomes

Primary Outcome Measures

Muscle strength
1 maximum repetition test.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2023
Last Updated
May 19, 2023
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Hospital de Clínicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05869370
Brief Title
The Effects Of Low Intensity Training With Blood Flow Restriction In Rheumatoid Arthritis Patients
Acronym
TBFR
Official Title
The Effects Of Low Intensity Training With Blood Flow Restriction In The Lower And Upper Limbs On Muscle Strength, Muscle Mass, Biochemical Parameters And Markers Of Systemic Inflammation In Rheumatoid Arthritis Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Hospital de Clínicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Rheumatoid arthritis (RA) patients showed systemic manifestations that may lead to a reduction in muscle strength, muscle mass and, consequently, to a reduction in physical function. On the other hand, high intensity resistance training (HIRT) are able to improve muscle strength and muscle mass in RA without affecting the disease course. However, due to the articular manifestations caused by this disease, these patients may present intolerance to HIRT. Thus, the low intensity resistance training with blood flow restriction (TBFR) may be a new training strategy for these populations. In this sense, the investigators speculate that TBFR could be beneficial in RA patients, as well as, HIRT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Kaatsu, Blood Flow Restriction Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity resistance training
Arm Type
Experimental
Arm Title
Low intensity resistance training combined with blood flow restriction
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High intensity resistance training
Intervention Description
Twelve weeks of resistance training twice a week.
Intervention Type
Other
Intervention Name(s)
Low intensity resistance training combined with blood flow restriction
Intervention Description
Twelve weeks of resistance training with blood flow restriction twice a week.
Primary Outcome Measure Information:
Title
Muscle strength
Description
1 maximum repetition test.
Time Frame
Twelve weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female; Rheumatoid arthritis patients; All individuals will undergo an ergospirometry to ensure cardiorespiratory conditions. Exclusion Criteria: Fibromyalgia; Cardiovascular disease;
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul - Faculdade de Medicina - Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo P. dos Santos, Master's degree
Phone
+55 (51)9 92840819
Email
leonardosantos@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Rafaela C.E. Santo, PhD
First Name & Middle Initial & Last Name & Degree
Ricardo M. Xavier, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34758045
Citation
Dos Santos LP, Santo RCDE, Ramis TR, Portes JKS, Chakr RMDS, Xavier RM. The effects of resistance training with blood flow restriction on muscle strength, muscle hypertrophy and functionality in patients with osteoarthritis and rheumatoid arthritis: A systematic review with meta-analysis. PLoS One. 2021 Nov 10;16(11):e0259574. doi: 10.1371/journal.pone.0259574. eCollection 2021.
Results Reference
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The Effects Of Low Intensity Training With Blood Flow Restriction In Rheumatoid Arthritis Patients

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