Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individualized comprehensive rehabilitation program
Aquatic training
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Comprehensive Rehabilitation program
Aquatic training
Arm Description
19 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.
18 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04138784
First Posted
October 23, 2019
Last Updated
November 11, 2019
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT04138784
Brief Title
Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis
Official Title
Effectiveness of an Individualized Comprehensive Rehabilitation Program in Disabled Chronic Knee Osteoarthritis Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues, and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that an individualized comprehensive rehabilitation program uring 8 weeks would benefit women with knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comprehensive Rehabilitation program
Arm Type
Experimental
Arm Description
19 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.
Arm Title
Aquatic training
Arm Type
Experimental
Arm Description
18 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.
Intervention Type
Other
Intervention Name(s)
Individualized comprehensive rehabilitation program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aquatic training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Functionality
Description
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.
Time Frame
Baseline, 8 weeks, 3 months
Title
Changes in Physical Performance
Description
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.
Time Frame
Baseline, 8 weeks, 3 months
Title
Changes in Physical Performance
Description
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.
Time Frame
Baseline, 8 weeks, 3 months
Title
Changes in Perceived Health Status
Description
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)
Time Frame
Baseline, 8 weeks, 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Phone
958242360
Email
cvalenza@ugr.es
12. IPD Sharing Statement
Citations:
PubMed Identifier
35674649
Citation
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.
Results Reference
derived
Learn more about this trial
Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis
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