NCT01850862

Brief Summary

The investigators hypothesized that an eight-week collective group exercise program would improve pain, quality of life and functional capacity in patients with knee osteoarthritis (KOA) compared with those receiving no exercise intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

May 4, 2013

Last Update Submit

May 15, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain

    pain assessed by Visual Analogue Scale

    Eight weeks

Secondary Outcomes (1)

  • quality of life

    Eight weeks

Other Outcomes (1)

  • functional capacity

    Eight weeks

Study Arms (2)

Collective group exercise program in patients with KOA

EXPERIMENTAL

Collective exercises program for patients with osteoarthritis and orientation about this disease

Other: Collective group exercise program in patients with KOA

Control group (without exercise)

ACTIVE COMPARATOR

Orientation about osteoarthritis disease but without any exercise program

Other: Orientation (without exercise)

Interventions

Collective group exercise program in patients with KOA

Orientation about osteoarthritis disease but without any exercise program

Control group (without exercise)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic and moderate to severe medical diagnostic of KOA.
  • Subjects with normal cognitive functions and no restriction to perform physical activities were recruited from the hospital's KOA database and eligible to participate if they had presented: Lequesne questionnaire criteria (5 - 13.5), knee pain score between 3 and 7 (on a 0 -10 Visual Analogue Scale), stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and no regular physical exercise or use of canes in the months prior to the study.

You may not qualify if:

  • Symptomatic heart disease; symptomatic disease of the lower limbs (other than KOA); symptomatic lung disease; severe systemic disease; severe psychiatric illness; regular physical exercise (three or more times per week for at least 3 months); drug injection in the knee in the previous 3 months; physiotherapy on the lower limbs in the previous 3 months and absence in two consecutive training sessions or three nonconsecutive sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59072-970, Brazil

Location

Related Publications (1)

  • da Silva FS, de Melo FE, do Amaral MM, Caldas VV, Pinheiro IL, Abreu BJ, Vieira WH. Efficacy of simple integrated group rehabilitation program for patients with knee osteoarthritis: Single-blind randomized controlled trial. J Rehabil Res Dev. 2015;52(3):309-22. doi: 10.1682/JRRD.2014.08.0199.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Wouber Hérickson de Brito Vieira, PhD

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR
  • Bento João Abreu, PhD

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

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 4, 2013

First Posted

May 10, 2013

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations