- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05869370
The Effects Of Low Intensity Training With Blood Flow Restriction In Rheumatoid Arthritis Patients (TBFR)
May 19, 2023 updated by: Ricardo Machado Xavier, Federal University of Rio Grande do Sul
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
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
28
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
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil
- Recruiting
- Universidade Federal do Rio Grande do Sul - Faculdade de Medicina - Hospital de Clínicas de Porto Alegre
-
Contact:
- Leonardo P. dos Santos, Master's degree
- Phone Number: +55 (51)9 92840819
- Email: leonardosantos@hcpa.edu.br
-
Sub-Investigator:
- Rafaela C.E. Santo, PhD
-
Principal Investigator:
- Ricardo M. Xavier, 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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female;
- Rheumatoid arthritis patients;
- All individuals will undergo an ergospirometry to ensure cardiorespiratory conditions.
Exclusion Criteria:
- Fibromyalgia;
- Cardiovascular disease;
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High intensity resistance training
|
Twelve weeks of resistance training twice a week.
|
|
Experimental: Low intensity resistance training combined with blood flow restriction
|
Twelve weeks of resistance training with blood flow restriction twice a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength
Time Frame: Twelve weeks
|
1 maximum repetition test.
|
Twelve weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
May 20, 2018
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
May 11, 2023
First Submitted That Met QC Criteria
May 19, 2023
First Posted (Actual)
May 22, 2023
Study Record Updates
Last Update Posted (Actual)
May 22, 2023
Last Update Submitted That Met QC Criteria
May 19, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0071
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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