Progressive Collective-exercise Program on the Knee Osteoarthritis
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Jun 2011
Shorter than P25 for not_applicable knee-osteoarthritis
1 active site
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
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 4, 2013
CompletedFirst Posted
Study publicly available on registry
May 10, 2013
CompletedMay 16, 2013
May 1, 2013
4 months
May 4, 2013
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
EXPERIMENTALCollective exercises program for patients with osteoarthritis and orientation about this disease
Control group (without exercise)
ACTIVE COMPARATOROrientation about osteoarthritis disease but without any exercise program
Interventions
Orientation about osteoarthritis disease but without any exercise program
Eligibility Criteria
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
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.
PMID: 26237073DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
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