NCT02881463

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

3.4 years

First QC Date

June 16, 2016

Last Update Submit

September 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle electromyographic (EMG) activity

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

    up to 12 months

Secondary Outcomes (7)

  • Knee joint pain intensity

    up to 12 months

  • Knee joint function

    up to 12 months

  • Sit to Stand test

    up to 12 months

  • Mobility test

    up to 12 months

  • Leg muscles strength

    up to 12 months

  • +2 more secondary outcomes

Study Arms (1)

Home Exercise Program

EXPERIMENTAL

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

Other: therapeutical exercises

Interventions

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.

Home Exercise Program

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Helena Gapeyeva, MD, PhD

    University of Tartu, Faculty of Medicine, Estonia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow, Md, PhD

Study Record Dates

First Submitted

June 16, 2016

First Posted

August 29, 2016

Study Start

January 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09