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Rheumatoid ArthritisTBFRNCT05869370

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

A study testing High intensity resistance training and Low intensity resistance training combined with blood flow restriction in people with Rheumatoid Arthritis, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years, women only
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
High intensity resistance training and Low intensity resistance training combined with blood flow restriction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteBrazil
Study dates
20 May 2018to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female;
  • Rheumatoid arthritis patients;
  • All individuals will undergo an ergospirometry to ensure cardiorespiratory conditions.

Who cannot join

  • Fibromyalgia;
  • Cardiovascular disease;

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

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

    Porto Alegre, Rio Grande do Sul

    Leonardo P. dos Santos, Master's degree, +55 (51)9 92840819, leonardosantos@hcpa.edu.br

    Rafaela C.E. Santo, PhD

    Recruiting

Other trials in Brazil

About this study

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

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.

Being tested
High intensity resistance training, Low intensity resistance training combined with blood flow restriction
Keywords
Rheumatoid Arthritis, Kaatsu, Blood Flow Restriction Training
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity resistance trainingOther

    Twelve weeks of resistance training twice a week.

  • Low intensity resistance training combined with blood flow restrictionOther

    Twelve weeks of resistance training with blood flow restriction twice a week.

Study groups in NCT05869370
Study groupRoleWhat they receive
High intensity resistance trainingExperimentalNot described
Receives: Other: High intensity resistance training
Low intensity resistance training combined with blood flow restrictionExperimentalNot described
Receives: Other: Low intensity resistance training combined with blood flow restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle strength

    1 maximum repetition test.

    Measured: Twelve weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start20 May 2018
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05869370
Sponsor's protocol ID
2018-0071
Acronym
TBFR
Status last verified
May 2023
First submitted
11 May 2023
Last updated
22 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34758045

Questions about this trial

What is this clinical trial studying?

A study testing High intensity resistance training and Low intensity resistance training combined with blood flow restriction in people with Rheumatoid Arthritis, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle strength (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05869370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.

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