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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
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 23, 2019
    Last Updated
    November 11, 2019
    Sponsor
    Universidad de Granada
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    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

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    Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis

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