NCT01099371

Brief Summary

The purpose of this study is to determine whether:

  1. 1.Progressive resistance training improves pain and disability
  2. 2.Progressive Resistance training improves muscular strength, ability to walk and quality of life

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
70

participants targeted

Target at P25-P50 for phase_2 knee-osteoarthritis

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 7, 2010

Status Verified

January 1, 2009

Enrollment Period

Same day

First QC Date

April 1, 2010

Last Update Submit

May 6, 2010

Conditions

Knee Osteoarthritis

Keywords

KneeOsteoarthritisExercise

Outcome Measures

Primary Outcomes (1)

  • Pain assessed on a 10-point numeric pain scale

    Scale: visual analog scale

    week 0

Secondary Outcomes (3)

  • Disability assessed on WOMAC

    week 6

  • Quality of life assessed on the SF-36

    week 6

  • Six-minute walk test

    week 12

Study Arms (1)

exercise

EXPERIMENTAL
Other: exercise

Interventions

exerciseOTHER

progressive resistance training

exercise

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman
  • Age between 40-70 years old
  • Pain between 3 and 8 on a 10-point numeric pain scale
  • Radiographically confirmed knee OA

You may not qualify if:

  • Inflammatory diseases or any comorbidity that prohibit exercises, regular physical activity
  • Trip plans for the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jamil Natour, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 7, 2010

Study Start

February 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2011

Last Updated

May 7, 2010

Record last verified: 2009-01

Locations

BR(1)