Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis
Effectiveness of an Individualized Comprehensive Rehabilitation Program in Disabled Chronic Knee Osteoarthritis Women
1 other identifier
interventional
38
0 countries
N/A
Brief Summary
Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks individualized comprehensive rehabilitation program with elastic bands on pain and functional disability in chronic knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable knee-osteoarthritis
Started Dec 2019
Shorter than P25 for not_applicable knee-osteoarthritis
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
First Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedNovember 13, 2019
November 1, 2019
2 months
October 23, 2019
November 11, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Changes in Functionality
Changes in Functionality is going to be assessed by the Western Ontario and McMaster Universities (WOMAC). Scores range from 0 to 96, with higher scores indicating greater disease severity.
Baseline, 8 weeks, 3 months
Changes in Physical Performance
Changes in Physical Performance is going to be assessed using the Stairs Climbing Test. This test assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.
Baseline, 8 weeks, 3 months
Changes in Physical Performance
Changes in Physical Performance is going to be assessed by The Timed up ad go. It involves a person standing from a 46-cm-high chair, walking 3 m, turning, walking back to the chair and sitting down.
Baseline, 8 weeks, 3 months
Changes in Perceived Health Status
Changes in Perceived Health Status is going to be assessed by the EuroQol-5D.It contains two sections, a descriptive section and a valuation section. The descriptive section is a health status classification instrument with the following five dimensions: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. In the second section, respondents are asked to value their overall health status on a visual analogue scale ranging from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state)
Baseline, 8 weeks, 3 months
Study Arms (2)
Comprehensive Rehabilitation program
EXPERIMENTAL19 women will be recruited in order to the inclusion criteria for the study and they will receive an 8-weeks individualized comprehensive rehabilitation program administered once a day.
Aquatic training
EXPERIMENTAL18 women will be recruited in order to the inclusion criteria for the study and they will receive an 8-weeks hydrotherapy intervention once a day.
Interventions
The program general contents were pain education, joint protection techniques, general care lifestyle habits, which were complemented by a problem-based session. The program plan was designed to fit patients' goals, priorities, and lifestyles after an initial interview.
Patients received a 45 min-water exercise program which included balance and proprioception activities, isometric exercise, flexibility exercises, core stabilization exercises and aerobic/endurance exercises. All sessions were developed in groups and addressed by a qualified professional.
Eligibility Criteria
You may qualify if:
- Diagnosis of primary symptomatic KOA according to the criteria of the American College of Rheumatology
- Women aged older than 65 years
- Pain predominantly over the last 3 months
- Kellgren and Lawrence score ≥2.
You may not qualify if:
- Ankle, hip or foot severe disorders
- Chronic back pain
- Alzheimer's disease, Parkinson's disease, motor neuron disorders.
- Diabetes mellitus
- Cardiac or respiratory insufficiency
- Inability to understand the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lopez LL, Benitez PO, Lopez JC, Martos IC, Torres JR, Santiago MG, Valenza MC. Effectiveness of an individualized comprehensive rehabilitation program in women with chronic knee osteoarthritis: a randomized controlled trial. Menopause. 2022 Jun 1;29(6):687-692. doi: 10.1097/GME.0000000000001959.
PMID: 35674649DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant profressor
Study Record Dates
First Submitted
October 23, 2019
First Posted
October 25, 2019
Study Start
December 1, 2019
Primary Completion
February 1, 2020
Study Completion
March 1, 2020
Last Updated
November 13, 2019
Record last verified: 2019-11