OA: Investigation of the Effects of Progressive Resistance Exercises in Individuals With Knee Osteoarthritis

Sponsor

Meltem Meran Çağlar (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05997966

Collaborator

(none)

Enrollment

Arms

14.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

It is known that the global socioeconomic burden of individuals with knee osteoarthritis (OA) is on a constantly rising curve. In addition, it is predicted that this burden will increase with the increase in the aging rate of countries. While the evidence level of exercise in the treatment of individuals with knee OA is at A level, a standard exercise program has still not been established for these individuals. One of the most important elements in establishing a standard exercise protocol can be realized by understanding how exercise provides positive effects in these individuals. Today, the gold standard practice used in examining the effectiveness of treatments such as exercise is the follow-up of biomarkers. However, for this purpose, biological fluids (blood, urine, synovial fluid) samples are not taken from individuals with knee OA during routine health controls. Existing laboratory detection methods, especially ELISA analysis, are very detailed, time-consuming and expensive, among the reasons why they cannot be included in routine clinical practice. This situation makes it difficult to examine which biomarkers the exercise programs applied in individuals with knee OA have an effect on and to establish a standard exercise protocol. Therefore, the number of randomized controlled studies examining this issue is very few in the literature, and this number is much less in Turkey. The researchers aimed to create a standard home-based exercise program by examining the effects of the holistic exercise approach for all lower extremity muscles, which the researchers created considering the EMG studies in the literature for individuals with knee OA and the age group to be included in the study, both at the physical (pain, functional status, quality of life) and biochemical level (inflammatory biomarkers that have not been examined together before and whose relationship with OA has been newly discovered).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Exercise Training Biomarkers	Other: Progresive Resistance Exercises Other: No intervation	N/A

Detailed Description

The researchers aim to evaluate the effectiveness of a home-based holistic progressive resistance exercise program for all lower extremity muscles (hip, knee and ankle circumference) in individuals with knee OA in detail and in a multifaceted manner. In addition, the researchers aim to examine the effect of exercise on serum biomarkers in order to understand whether exercise has an anti-inflammatory effect in these individuals and to establish standard exercise protocols. Thus, when a standard home-based exercise program can be established, it will be ensured that elderly individuals with knee OA, who have problems in reaching health centers, have difficulty in going out due to different health problems, and who are the primary care treatment, will be able to do exercises at home. At the same time, considering the global socioeconomic burden of knee OA, the researchers predict that the home-based exercise program will contribute positively to the country's economy.

All subjects who voluntarily accepted to participate in the study and met the inclusion criteria will be applied four times during the 12-week exercise program (except for the blood draw required for the evaluation of serum biomarker levels). Pain intensity, functional status based on performance and scales, quality of life, lower extremity range of motion, lower extremity muscle strength assessments will be repeated before treatment (0 weeks), 5th and 9th weeks, and after treatment (13th week). These assessments will be made at patients' homes. Blood collection will be done before treatment (week 0) and after treatment (week 13) to examine serum biomarker levels with ELISA kits.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Investigation of the Effects of Progressive Resistance Exercises on Pain, Functional Activity, Quality of Life and Serum Biomarkers in Individuals With Knee Osteoarthritis

Anticipated Study Start Date :

Aug 28, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Progressive Resistance Exercises Group In the exercise group, a home-based exercise program will be applied in addition to a 30-minute walking request twice a week, and will consist of stretching exercises for the lower extremities, isometric exercises and progressive resistance strengthening exercises (IDE) of the hip, knee and ankle. The 12-week home-based IDE program will be applied 2 sets/day for 3 days/week (on non-consecutive days). Resistance bands will be used for resistance in the IDE program. In addition, the exercise intensity in the IDE program will be questioned with the perceived difficulty level (AZD). The AZD scale shows the perceived intensity and pulse rate change during exercise between 6-20. All exercises will be performed without resistance for the first 4 weeks, with AZD levels at 40% of 1 maximum repetition at week 5 to 8, AZD 13-15 (somewhat difficult), and after week 8 to AZD 15-16 (difficult). Progress will be achieved by increasing the number of repetitions.	Other: Progresive Resistance Exercises At the beginning of the study, there will be a home visit (week 0) where the exercises will be taught. Exercise brochures explaining the exercises in written and visual form will also be given to each participant during the first and subsequent home visits. After the first home visit, individuals will be asked to keep an exercise diary prepared by the physiotherapist in order to control the exercises, the occurrence of side effects and dependence on the treatment, and information will be obtained from the individuals by phone calls every week. Two more home visits will take place in weeks 5 and 9 to further the IDE program. Apart from these visits and phone calls, the participant will be allowed to call the physiotherapist if needed. In the exercise group, the 12-week home-based IDE program will be applied 2 sets/day for 3 days/week (on non-consecutive days).
Sham Comparator: Control Group In the control group, 30 minutes of walking will be requested twice a week, and no other intervention will be made. Individuals in the control group will be called every week by phone for gait follow-up.	Other: No intervation After a general education about osteoarthritis in the control group, 30 minutes of walking will be requested twice a week, and no other intervention will be made.

Arm

Intervention/Treatment

Active Comparator: Progressive Resistance Exercises Group

In the exercise group, a home-based exercise program will be applied in addition to a 30-minute walking request twice a week, and will consist of stretching exercises for the lower extremities, isometric exercises and progressive resistance strengthening exercises (IDE) of the hip, knee and ankle. The 12-week home-based IDE program will be applied 2 sets/day for 3 days/week (on non-consecutive days). Resistance bands will be used for resistance in the IDE program. In addition, the exercise intensity in the IDE program will be questioned with the perceived difficulty level (AZD). The AZD scale shows the perceived intensity and pulse rate change during exercise between 6-20. All exercises will be performed without resistance for the first 4 weeks, with AZD levels at 40% of 1 maximum repetition at week 5 to 8, AZD 13-15 (somewhat difficult), and after week 8 to AZD 15-16 (difficult). Progress will be achieved by increasing the number of repetitions.

Other: Progresive Resistance Exercises

At the beginning of the study, there will be a home visit (week 0) where the exercises will be taught. Exercise brochures explaining the exercises in written and visual form will also be given to each participant during the first and subsequent home visits. After the first home visit, individuals will be asked to keep an exercise diary prepared by the physiotherapist in order to control the exercises, the occurrence of side effects and dependence on the treatment, and information will be obtained from the individuals by phone calls every week. Two more home visits will take place in weeks 5 and 9 to further the IDE program. Apart from these visits and phone calls, the participant will be allowed to call the physiotherapist if needed. In the exercise group, the 12-week home-based IDE program will be applied 2 sets/day for 3 days/week (on non-consecutive days).

Sham Comparator: Control Group

In the control group, 30 minutes of walking will be requested twice a week, and no other intervention will be made. Individuals in the control group will be called every week by phone for gait follow-up.

Other: No intervation

After a general education about osteoarthritis in the control group, 30 minutes of walking will be requested twice a week, and no other intervention will be made.

Outcome Measures

Primary Outcome Measures

Chair Stand Test [Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).]
A standard chair will be used for the test. First of all, the patient will be asked to sit with his back to the chair. Then, he will be asked to get up from the seat without holding on to the arms of the chair, walk with regular steps at a predetermined length of 3 m, and return to the chair at the end of 3 m. Each patient will be asked to walk at a normal pace and the time will be recorded in seconds with a digital stopwatch.
Timed Up and Go Test [Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).]
A standard chair will be used for the test. First of all, the patient will be asked to sit with his back to the chair. Then, he will be asked to get up from the seat without holding on to the arms of the chair, walk with regular steps at a predetermined length of 3 m, and return to the chair at the end of 3 m. Each patient will be asked to walk at a normal pace and the time will be recorded in seconds with a digital stopwatch. The walking distance will be measured with a tape measure and marked with a colored tape.
Range of Motion [Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).]
Active hip, knee, and ankle joint range of motion will be measured using a universal goniometer. It has been shown that goniometric measurement is a reliable and valid outcome measure in patients with knee OA (Maricar et al., 2016). Hip flexion, abduction, adduction, ankle dorsi and plantar flexion measurements were in supine position; hip extension, knee flexion and extension measurements will be performed in the prone position. Each assessment will be repeated three times, and their average value will be recorded.
Muscle Strength [Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).]
Assessment of muscle strength will be made with a Lafayette manual muscle tester (Lafayette Instrument Company, Lafayette, USA). Measurements will be made in hip abduction, adduction, flexion and extension, knee flexion and extension movements. Measurements will be made in three repetitions for hip abduction, adduction, flexion and extension, with one minute rest between each hip movement and 15 seconds between each repetition. The best values obtained from triple repetitive measurements will be used in the analysis (Mentiplay et al., 2015). Strength measurement of iliopsoas, gluteus maximus, gluteus medius, quadriceps femoris, harmstring, adductor longus and brevis, plantar and dorsi flexor muscles will be performed.
Serum Inflammatory Level [Blood collection will be done before treatment (week 0) and after treatment (week 13) to examine serum biomarker levels with ELISA kits.]
All measurements of serum biomarkers [plasma-soluble TNF-α and TNF-α receptors 1 (sTNFR1), 2 (sTNFR2), serum resistin, IL-1β, IL-6, IL-17, MMP-1 and MMP-3] are strictly aseptic. Under these conditions, 10 ml of venous blood will be drawn from each individual. After centrifugation of the clotted blood at 3000 rpm for 20 minutes, the separated serum samples will be portioned and frozen at -20 C and stored under these conditions until analysis.
Visual Analogue Scale (VAS) [Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).]
It will be used to evaluate the severity of pain. The severity of the pain will be determined by marking a place on a 10 cm straight line drawn between the points of no pain (0) and unbearable pain (10). An increase in the score indicates an increase in pain intensity.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).]
It is a disease-specific health status measure that is frequently used in patients with knee and hip OA, which consists of three parts (pain, stiffness, and function). WOMAC Turkish version has been shown to be a reliable, valid, sensitive and acceptable outcome measure. WOMAC consists of 24 questions, 5 questions in the pain section, 2 questions in the stiffness section, and 17 questions in the function section. A total score is obtained by scoring each question between 0 and 4 points. Patients are asked to answer the questions by considering the pain, stiffness and activities they have difficulty in performing in the last 24 hours.
Quality of Life Scale-Short Form (SF-12) [Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).]
The 12-item short form health questionnaire (SF-12) is a measure that evaluates physical and mental health. It was reported that SF-12, which was created from the original form, SF-36, was easier to apply and had a shorter completion time and was more advantageous to use.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Having signed the informed consent form,
Male and postmenopausal female patients aged 50 and over,
Radiologically and clinically diagnosed with Stage 1 or 2 knee OA,
Patients with a sedentary life (patients with less than 45 minutes of moderate-intensity activity per week)

Exclusion Criteria:

Cooperative problem or cognitive impairment,
BMI > 35 kg/m2,
Receiving physiotherapy in the last 3 months,
Steroid injection to the knee joint in the last 6 months,
Presence of neuromuscular or neurodegenerative disease,
Presence of cardiorespiratory disease, previous hip, knee, foot-ankle surgeries,
Use of immunosuppressive drugs,
Presence of infection or inflammatory disease in any part of the body.