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

NCT ID: NCT04588558

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2021-04-02

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.

Detailed Description

OA is endemic around the world. About 30.8 million adults in the United States and 300 million people worldwide live with OA. OA is a disease of the entire joint involving structural changes in articular cartilage, subchondral bone, ligaments, capsule, synovial membrane, and periarticular muscles. Clinically, OA is characterized by joint pain, tenderness, limitation of movement, crepitus, effusion and varying degrees of non-systemic inflammation. Pain, stiffness and difficulty in daily life activities due to the negative impact of functional status are among the main symptoms. The knee is the most affected joint.

The aim of this study is to compare effect to three groups (flywheel exercise, electrotherapy modality and home exercise) 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.

Electrophysical agents are used by physiotherapists to treat a wide variety of conditions. Electrotherapy modalities especially transcutaneous electrical nerve stimulation (TENS) and ultrasound is used to treat OA

Hypothesis:

• Ho: Three different protocols applied in individuals with knee osteoarthritis have no effect.
• H1-0: It is effective in three different protocols applied in individuals with knee osteoarthritis, but three don't have statistically effect on each other.
• H1-1: Exercise with isoinertial system in individuals with knee osteoarthritis to be more effective than other treatment protocols
• H1-2: Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program is more effective than other treatment protocols in individuals with knee osteoarthritis.
• H1-3: Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program in individuals with knee osteoarthritis to be more effective than other treatment protocols

Randomization and blinding

After the baseline assessment, the participants were randomized to one of three intervention groups (ratio 1:1:1) using "Research Randomizer," an online randomization web service (https://www.randomizer.org/).

It was planned as a double-blind study without knowing the necessary treatment or experimental condition for both the subject and the researchers.

Sample size

Sample size was determined using an Instat sample size calculator. In the WOMAC sections, the smallest detectable difference and minimal clinically important difference ranged from 0.51 to 1.33 points. This value was used to calculate the sample size (Angst, Aeschlimann, and Stucki, 2001). Investigators included a two sided alpha value of 0.05, a power of 0.9, and a sample size of 21 per group. To allow for dropouts, the sample size was set at 25 per group.

Risk management:

Failure to reach the number of patients, receiving support from other hospitals of the Medipol Hospital Group Unusual increase in the rate of increase of Covid 19 outbreak, (second wave, permanent curfew): Online controlled (tele-rehabilitation) exercises

Research center

Sefaköy Medipol University Hospital Health Practice and Research Center Statistical method (s) to be used

Statistical analysis will be calculated using SPSS for Windows 22 program.

Conditions

Osteoarthritis Knees Both; Pain, Chronic; Walking, Difficulty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Flywheel exercise

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.

Group Type: EXPERIMENTAL

Flywheel exercise

Intervention Type: 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

Electrotherapy modality

Electrotherapy modalities especially transcutaneous electrical nerve stimulation (TENS) and ultrasound is used to treat OA.

All participants received home exercise for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Electrotherapy group

Intervention Type: 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

Home exercise

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.

Group Type: ACTIVE_COMPARATOR

Home exercise

Intervention Type: 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.

Interventions

Flywheel exercise

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

Intervention Type: DEVICE

Home exercise

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.

Intervention Type: OTHER

Electrotherapy group

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The age range is between 40-65 years old

2. According to ACR criteria, clinically and radiographically, at least one of the knees should be diagnosed with knee OA (within the last 6 months)

3. Having findings consistent with Kellgren-Lawrence grade II-III OA on knee radiography

4. Pain between 2-7 according to the visual analog scale

Exclusion Criteria

1. Acute OA in the knee

2. Comorbid diseases (advanced osteoporosis, vertigo, neurological diseases, etc.), injuries and surgeries where exercise is contraindicated

3. Use of NSAIDs and similar disease modifying drugs (Diacerein, Glucosamine etc.) in the last month

4. Having exercised regularly in the last 6 months (more than 1 day a week)

5. Having had arthroplasty surgery

6. Intra-articular injection (hyaluronic acid / steroid) application in the last 6 months

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bahçeşehir University

OTHER

Sponsor Role: collaborator

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hazal genc

Phd(c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medipol University Sefaköy Research and Application Hospital

Istanbul, Küçükçekmece, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

hazalgenc

Identifier Type: -

Identifier Source: org_study_id