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Prehabilitation Physical Activity in Persons With Osteoarthritis (PrehabOA)

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
therapeutical exercises
Sponsored by
University of Tartu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • For OA patients: patients with severe knee joint OA undergoing unilateral total knee arthroplasty (TKA)
  • for controls: pain of joints more than 20/100 mm by VAS

Exclusion Criteria:

For both groups:

  • previous total joint arthroplasty of lower limbs
  • other musculoskeletal, neurological and cardiovascular diseases
  • any diseases affecting balance and coordination.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Home Exercise Program

    Arm Description

    8- week therapeutical exercise program performing at home for women with knee joint osteoarthritis

    Outcomes

    Primary Outcome Measures

    Muscle electromyographic (EMG) activity
    Electromyographic (EMG) activity of thigh muscles during gait and sit to stand task (amplitude, mV)

    Secondary Outcome Measures

    Knee joint pain intensity
    Self-reported knee joint pain intensity measured by visual-analogue scale (VAS) (in mm: "0 mm" - no pain and "100 mm" - extreme pain)
    Knee joint function
    Self-reported functional status measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms, Pain, Daily Living Activity, Sport and Recreational Activity. Quality of Life. Maximum is 100 points (complains are absent) and minimum is 0 points (extreme complains)
    Sit to Stand test
    five time Sit to Stand test from standard chair (s)
    Mobility test
    Timed Up and Go test, 3-m plus return 3-m walking test (s)
    Leg muscles strength
    strength of leg extensor muscles (N)
    Body balance
    Body postural sway measuring during standing using Kistler force plate (Switzerland) (mm), eyes open and eyes closed
    Gait pattern
    Gait kinematic characteristics measurement using three-dimensional movement analysis system and six optoelectronic cameras (BTS S.p.A. Italy) - joint angles (degrees)

    Full Information

    First Posted
    June 16, 2016
    Last Updated
    September 12, 2016
    Sponsor
    University of Tartu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02881463
    Brief Title
    Prehabilitation Physical Activity in Persons With Osteoarthritis
    Acronym
    PrehabOA
    Official Title
    Prehabilitation Physical Activity: Relationship With Muscle Function, Postural Stability and Postoperative Recovery in Persons With Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Tartu

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks such as rising from a chair. Therefore interventions aimed at improving muscle strength and sit-to-stand task performance are very important for these patients. The effect of exercise programs, including home exercise programs (HEP), on muscle strength, joint pain and function is well known and widely researched, yet not many studies have investigated the effect of an HEP on electromyographic activity (EMG) of muscles when performing everyday tasks, such as rising from and sitting on a chair. The aim of this study was to investigate effect of prehabilitation in women with severe knee joint OA scheduled for knee joint arthroplasty (TKA).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Home Exercise Program
    Arm Type
    Experimental
    Arm Description
    8- week therapeutical exercise program performing at home for women with knee joint osteoarthritis
    Intervention Type
    Other
    Intervention Name(s)
    therapeutical exercises
    Intervention Description
    Participants of experimental group performs daily an 8-week home therapeutical exercise program. Exercises are periodized by weeks (1-8 weeks). The aim of program is the leg muscle strengthening using an elastic band (Thera-Band, System of Progressive Exercise, USA), body balance training, and leg muscle stretching.
    Primary Outcome Measure Information:
    Title
    Muscle electromyographic (EMG) activity
    Description
    Electromyographic (EMG) activity of thigh muscles during gait and sit to stand task (amplitude, mV)
    Time Frame
    up to 12 months
    Secondary Outcome Measure Information:
    Title
    Knee joint pain intensity
    Description
    Self-reported knee joint pain intensity measured by visual-analogue scale (VAS) (in mm: "0 mm" - no pain and "100 mm" - extreme pain)
    Time Frame
    up to 12 months
    Title
    Knee joint function
    Description
    Self-reported functional status measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms, Pain, Daily Living Activity, Sport and Recreational Activity. Quality of Life. Maximum is 100 points (complains are absent) and minimum is 0 points (extreme complains)
    Time Frame
    up to 12 months
    Title
    Sit to Stand test
    Description
    five time Sit to Stand test from standard chair (s)
    Time Frame
    up to 12 months
    Title
    Mobility test
    Description
    Timed Up and Go test, 3-m plus return 3-m walking test (s)
    Time Frame
    up to 12 months
    Title
    Leg muscles strength
    Description
    strength of leg extensor muscles (N)
    Time Frame
    up to 12 months
    Title
    Body balance
    Description
    Body postural sway measuring during standing using Kistler force plate (Switzerland) (mm), eyes open and eyes closed
    Time Frame
    up to 12 months
    Title
    Gait pattern
    Description
    Gait kinematic characteristics measurement using three-dimensional movement analysis system and six optoelectronic cameras (BTS S.p.A. Italy) - joint angles (degrees)
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: For OA patients: patients with severe knee joint OA undergoing unilateral total knee arthroplasty (TKA) for controls: pain of joints more than 20/100 mm by VAS Exclusion Criteria: For both groups: previous total joint arthroplasty of lower limbs other musculoskeletal, neurological and cardiovascular diseases any diseases affecting balance and coordination.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helena Gapeyeva, MD, PhD
    Organizational Affiliation
    University of Tartu, Faculty of Medicine, Estonia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Prehabilitation Physical Activity in Persons With Osteoarthritis

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