NCT05869370

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2018

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

7.5 years

First QC Date

May 11, 2023

Last Update Submit

May 19, 2023

Conditions

Keywords

Rheumatoid ArthritisKaatsuBlood Flow Restriction Training

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    1 maximum repetition test.

    Twelve weeks

Study Arms (2)

High intensity resistance training

EXPERIMENTAL
Other: High intensity resistance training

Low intensity resistance training combined with blood flow restriction

EXPERIMENTAL
Other: Low intensity resistance training combined with blood flow restriction

Interventions

Twelve weeks of resistance training twice a week.

High intensity resistance training

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

Low intensity resistance training combined with blood flow restriction

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Fibromyalgia;
  • Cardiovascular disease;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34758045BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 22, 2023

Study Start

May 20, 2018

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations