Clinical trial NCT04588558: Investigation of the Effectiveness of a Structured Squat-based Program in Knee Osteoarthritis Rehabilitation
Official title: Investigation of the Effectiveness of a Structured Squat-based Program in Knee Osteoarthritis Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Knees Both
Pain, Chronic
Walking, Difficulty
Keywords: Osteoarthritis, Knee
Muscle Activation
Exercise
Pain
Fly wheel
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Bahçeşehir University
First posted: 2020-10-19
Enrollment: 75
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 10 minutes
Secondary outcomes:
measure: EMG-BF
timeFrame: 10 minutes
measure: Muscle strength
timeFrame: 10 minutes
measure: Algometer
timeFrame: 5 minutes
measure: Visual Analog Scale (VAS) Evaluation
timeFrame: 5 minutes
measure: Time up and go test
timeFrame: 20 seconds
measure: 30 Seconds Sit To Stand Test
timeFrame: 30 Seconds
measure: Step test
timeFrame: 1 minute
measure: goniometer
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University Sefaköy Research and Application Hospital
state: Küçükçekmece
Study officials:
References: