Investigation of the Effectiveness of a Structured Squat-based Program in Knee Osteoarthritis Rehabilitation

NCT04588558 | Completed

• 1 other identifier: hazalgenc
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the study is to examine the effect of squat-based exercise approach in individuals with knee osteoarthritis. The aim of this study is to compare effect to three groups (flywheel exercise group, electrotherapy modality group and home exercise group) and also decrease the pain, increase muscle strength, activation values and increase the functional level of individuals. Osteoarthritis is the most common rheumatological disease in the world that primarily results in progressive cartilage destruction. Changes occurring as a result of osteoarthritis are the main cause of disability and are most common in the knee joint. Osteoarthritis; problems such as pain, tenderness, joint stiffness, joint swelling, movement restriction, joint deformities, loss of muscle strength, decreased functional capacity and impaired quality of life are observed. The daily life activities of individuals with knee osteoarthritis are restricted by the problems of walking up and down stairs, getting out of the chair, standing, squatting, walking. Improving the symptoms of the disease is an important goal of the rehabilitation process of patients with knee osteoarthritis. In individuals with knee osteoarthritis, joint structure and deformation in cartilage also show loss of strength with muscles. Strengthening exercises have been used in patients with knee osteoarthritis for a long time. Squat exercise is a type of exercise that is widely used as a strengthening exercise.

Conditions

Osteoarthritis Knees Both; Pain, Chronic; Walking, Difficulty

Keywords

Osteoarthritis, Knee; Muscle Activation; Exercise; Pain; Fly wheel

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  The primary outcome measures included the level of function determined by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) . WOMAC is a specific, valid, reliable criterion for knee osteoarthritis and includes 24 questions under three subheadings: pain, stiffness and physical function. Each question was scored according to the Likert scale as 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

  10 minutes

Secondary Outcomes (8)

• EMG-BF

  10 minutes

• Muscle strength

  10 minutes

• Algometer

  5 minutes

• Visual Analog Scale (VAS) Evaluation

  5 minutes

• Time up and go test

  20 seconds

Study Arms (3)

Flywheel exercise

EXPERIMENTAL

The term isoinertial is derived from the words iso (same) and inertial (resistance), which define the primary concept of the isoinertial system in a terminology or that expresses both the concentric and eccentric phases of the same muscle contraction. Isoinertial refers to resistance used in exercise training, maintaining a constant inertia throughout the range of motion, a constant resistance in all respects, and facilitating maximum muscle strength. All participants received home exercise for 8 weeks.

Device: Flywheel exercise

Electrotherapy modality

ACTIVE COMPARATOR

Electrotherapy modalities especially transcutaneous electrical nerve stimulation (TENS) and ultrasound is used to treat OA. All participants received home exercise for 8 weeks.

Device: Electrotherapy group

Home exercise

ACTIVE COMPARATOR

All participants received home exercise three times a week for 8 weeks. Home exercises are structured with squats. The exercise program includes stretching exercises and strengthening (isometric and isotonic) exercises.

Other: Home exercise

Interventions

Flywheel exercise DEVICE

Flywheel training is a strength training modality that offers the possibility of performing exercises with eccentric overload and variable resistance as compared to conventional gravity-based resistance training. Flywheel exercise applied three days a week for 8 weeks

Flywheel exercise

Home exercise OTHER

The active ROM exercise was performed via knee in extension to full-flexion, then knee in flexion to full-extension exercises, repeated 10 times. The strengthening exercises consisted of quadriceps strengthening by holding maximal isometric contractions for 10 s and performing 10 repetitions. Stretching targeted the gastrocnemius- soleus and hamstring muscle and was performed by asking the patient to stretch the muscle for 30 s and to complete three repetitions for each muscle group.

Home exercise

Electrotherapy group DEVICE

The participants in the electrotherapy group received TENS (Intellect; Chattanooga Group, Hixson, TN), therapeutic ultrasound (Intellect 340 Combo) and exercise. TENS was applied via four electrodes around the knee joint: two on the medial and two on the lateral aspect on either side of the joint line for approximately 20 min. For pain relief, the devices were set to a continuous mode (110 Hz, 50 μ). Electrical pulses were asymmetric and biphasic. Therapeutic pulsed ultrasound therapy was administered using a 1-MHz frequency, 0.8 W/cm power ultrasound device with a sound-head area of 5 cm2 and effective radiating area of 3.5-5 cm2 . Ultrasound was applied to the medial and lateral parts of the knee in circular movements for a duration of 5 min with the patient in a supine position. All participants received the same standardized exercise program. The exercises included aerobic, active ROM, strength, and stretching exercises

Electrotherapy modality

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age range is between 40-65 years old
• According to ACR criteria, clinically and radiographically, at least one of the knees should be diagnosed with knee OA (within the last 6 months)
• Having findings consistent with Kellgren-Lawrence grade II-III OA on knee radiography
• Pain between 2-7 according to the visual analog scale

You may not qualify if:

• Acute OA in the knee
• Comorbid diseases (advanced osteoporosis, vertigo, neurological diseases, etc.), injuries and surgeries where exercise is contraindicated
• Use of NSAIDs and similar disease modifying drugs (Diacerein, Glucosamine etc.) in the last month
• Having exercised regularly in the last 6 months (more than 1 day a week)
• Having had arthroplasty surgery
• Intra-articular injection (hyaluronic acid / steroid) application in the last 6 months

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Bahçeşehir University: collaborator

Study Sites (1)

Medipol University Sefaköy Research and Application Hospital

Istanbul, Küçükçekmece, 34295, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain; Mobility Limitation; Osteoarthritis, Knee; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd(c)

Model Details: Squat based exercise will be applied to the first group with isoinertial system. Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program will be applied to the second group, and only squat-based home exercise program will be applied to the third group.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: September 15, 2020
• Primary Completion: February 5, 2021
• Study Completion: April 2, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

TU (1)