Prehabilitation Physical Activity in Persons With Osteoarthritis (PrehabOA)

Prehabilitation Physical Activity: Relationship With Muscle Function, Postural Stability and Postoperative Recovery 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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: therapeutical exercises

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Exercise Program; 8- week therapeutical exercise program performing at home for women with knee joint osteoarthritis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle electromyographic (EMG) activity	Electromyographic (EMG) activity of thigh muscles during gait and sit to stand task (amplitude, mV)	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Sit to Stand test	five time Sit to Stand test from standard chair (s)	up to 12 months
Mobility test	Timed Up and Go test, 3-m plus return 3-m walking test (s)	up to 12 months
Leg muscles strength	strength of leg extensor muscles (N)	up to 12 months
Body balance	Body postural sway measuring during standing using Kistler force plate (Switzerland) (mm), eyes open and eyes closed	up to 12 months
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

Collaborators and Investigators

• Sponsor: University of Tartu
• Investigators: Principal Investigator: Helena Gapeyeva, MD, PhD, University of Tartu, Faculty of Medicine, Estonia

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 218/T-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided