Investigation of the Effectiveness of a Structured Squat-based Program in Knee Osteoarthritis Rehabilitation
Condition: Osteoarthritis Knees Both; Pain, Chronic; Walking, Difficulty
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain; Mobility Limitation
Study type: Interventional

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.
    

Intervention name(s): Flywheel exercise; Home exercise; Electrotherapy group
Intervention type(s): Device; Other; Device
Intervention description(s): 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; 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.; 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
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Muscle Activation; Exercise; Pain; Fly wheel