Prehabilitation Physical Activity in Persons With Osteoarthritis

Osteoarthritis Clinical Trial

— PrehabOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881463
• Other study ID #: 218/T-16
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2016
• Last updated: September 12, 2016
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: Research Ethics Committee of the University of Tartu
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• therapeutical exercises
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle electromyographic (EMG) activity	Electromyographic (EMG) activity of thigh muscles during gait and sit to stand task (amplitude, mV)	up to 12 months	Yes
Secondary	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)	up to 12 months	Yes
Secondary	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)	up to 12 months	Yes
Secondary	Sit to Stand test	five time Sit to Stand test from standard chair (s)	up to 12 months	Yes
Secondary	Mobility test	Timed Up and Go test, 3-m plus return 3-m walking test (s)	up to 12 months	Yes
Secondary	Leg muscles strength	strength of leg extensor muscles (N)	up to 12 months	Yes
Secondary	Body balance	Body postural sway measuring during standing using Kistler force plate (Switzerland) (mm), eyes open and eyes closed	up to 12 months	Yes
Secondary	Gait pattern	Gait kinematic characteristics measurement using three-dimensional movement analysis system and six optoelectronic cameras (BTS S.p.A. Italy) - joint angles (degrees)	up to 12 months	Yes