NCT01483157

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.

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
30

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2011

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

4 years

First QC Date

November 29, 2011

Last Update Submit

February 27, 2014

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • muscle strength

    twelve weeks

Secondary Outcomes (1)

  • quality of life

    twelve weeks

Study Arms (3)

low intensity with vascular occlusion

EXPERIMENTAL
Other: vascular occlusion with exercise trainig

high intensity resistance training

EXPERIMENTAL
Other: high intensity resistance training

no exercise training

NO INTERVENTION

Interventions

vascular occlusion with exercise trainigOTHER

twelve weeks of resistance training with vascular occlusion twice a week

low intensity with vascular occlusion
high intensity resistance trainingOTHER

twelve weeks of resistance training twice a week

high intensity resistance training

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo - School of Medicine - Clinical Hospital

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31033228DERIVED

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

BR(1)