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OpenTrials
Completed

NCT Number: NCT02881463

Prehabilitation Physical Activity in Persons With Osteoarthritis

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).

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

therapeutical exercises

Other

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 outcomes

  1. Muscle electromyographic (EMG) activity

    Time frame: up to 12 months

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

Secondary outcomes

  1. Knee joint pain intensity

    Time frame: up to 12 months

    Self-reported knee joint pain intensity measured by visual-analogue scale (VAS) (in mm: "0 mm" - no pain and "100 mm" - extreme pain)

  2. Knee joint function

    Time frame: up to 12 months

    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)

  3. Sit to Stand test

    Time frame: up to 12 months

    five time Sit to Stand test from standard chair (s)

  4. Mobility test

    Time frame: up to 12 months

    Timed Up and Go test, 3-m plus return 3-m walking test (s)

  5. Leg muscles strength

    Time frame: up to 12 months

    strength of leg extensor muscles (N)

  6. Body balance

    Time frame: up to 12 months

    Body postural sway measuring during standing using Kistler force plate (Switzerland) (mm), eyes open and eyes closed

  7. Gait pattern

    Time frame: up to 12 months

    Gait kinematic characteristics measurement using three-dimensional movement analysis system and six optoelectronic cameras (BTS S.p.A. Italy) - joint angles (degrees)

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Official study title

Prehabilitation Physical Activity: Relationship With Muscle Function, Postural Stability and Postoperative Recovery in Persons With Osteoarthritis

Acronym: PrehabOA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2016
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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