Exercise Dosages and Exercise Adherence With Patients With Knee Osteoarthritis

NCT04357145 | Unknown

• 1 other identifier: 563254
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although the effects of different exercise dosages for patients with osteoarthritis are compared in the literature, it is seen that studies on which exercise dosage is better are insufficient.The planned study has 2 main objectives:

• To examine the effects of different exercise dosages on exercise dependence
• To investigate the effect of different exercise dosages on pain and functional results

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Exercise Adherence; Exercise Dosage; Home Exercises

Outcome Measures

Primary Outcomes (3)

• Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Points at 12 weeks

  (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  Baseline, Week 3, Week 6 and Week 12

• Change from Exercise Adherence (with Self Reported Exercise Diary) at 12 Weeks Percentages at 12 Weeks

  In the exercise diary, the participant will note the number of exercises done at home next to the image showing the exercise example day by day.The percentage adherence to the prescribed exercise regimen was calculated by dividing the number of exercises performed by the number of exercises prescribed and multiplying by 100.

  Week 3, Week 6, Week 9, Week 12

• Change from Knee Osteoarthritis Exercise Adherence Scale Points at 12 Weeks

  It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.

  Week 3, Week 6, Week 9, Week 12

Secondary Outcomes (4)

• Change from Visual Analogue Scale(for Pain) Points at 12 Weeks

  Baseline, Week 3, Week 6 and Week 12

• Change from Tampa Scale for Kinesiophobia Points at 12 Weeks

  Baseline, Week 3, Week 6 and Week 12

• Change from Timed Up&Go Test Score at 12 Weeks

  Baseline, Week 3, Week 6 and Week 12

• Change from Timed 10 Meter Walk Test Score at 12 Weeks

  Baseline, Week 3, Week 6 and Week 12

Study Arms (2)

Standard Exercise Group

ACTIVE COMPARATOR

Exercise training is given to patients in the form of a home exercise program.

Other: Standard Dosage Home Exercise Training

High Dosage Exercise Group

EXPERIMENTAL

The high dosage exercise training group will implement the recommended exercise program 3 times more than the standard exercise group.

Other: High Dosage Home Exercise Training

Interventions

High Dosage Home Exercise Training OTHER

By giving more exercise to the experimental group, exercise adherence, pain and functionality will be compared with the standard exercise group. 3 times more reputation than control Exercise Program to be Applied (0-3 Weeks): Isometric knee extensor and adductor exercise * Hamstring stretching exercise * Terminal knee extension exercise * Straight leg lifting exercise Exercise Program to be Applied (3-12 Weeks): * Stepping exercise * Sit up and stand up without support * Active knee flexion exercise * Moving forward exercise

High Dosage Exercise Group

Standard Dosage Home Exercise Training OTHER

5-6 standard reputations for all exercises Exercise Program to be Applied (0-3 Weeks): Isometric knee extensor and adductor exercise * Hamstring stretching exercise * Terminal knee extension exercise * Straight leg lifting exercise Exercise Program to be Applied (3-12 Weeks): * Stepping exercise * Sit up and stand up without support * Active knee flexion exercise * Moving forward exercise

Standard Exercise Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a diagnosis of unilateral or bilateral knee osteoarthritis.
• Being between stage 1-3 according to Kellgren-Lawrence criteria.
• Having at least 3 months of pain duration and decreased functioning.
• Being a volunteer who can read and write

You may not qualify if:

• Physiotherapy or other conservative therapy during the previous 3 months or a history of major knee trauma.
• Having Inflammatory joint disease, hip symptoms more aggravating than the knee symptoms,
• Having comorbidities not allowing exercise such as cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance.
• Participants with previously performed knee replacement surgery

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Philosophy

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share