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

Primary Purpose

Osteoarthritis, Knee, Exercise Training, Biomarkers

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Progresive Resistance Exercises
No intervation
Sponsored by
Meltem Meran Çağlar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Exercise Training, Pain, Functional Status, Biomarkers, Quality of Life

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Progressive Resistance Exercises Group

    Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Chair Stand Test
    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
    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
    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
    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
    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)
    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)
    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)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 22, 2023
    Last Updated
    August 16, 2023
    Sponsor
    Meltem Meran Çağlar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05997966
    Brief Title
    Investigation of the Effects of Progressive Resistance Exercises in Individuals With Knee Osteoarthritis
    Acronym
    OA
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 28, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Meltem Meran Çağlar

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee, Exercise Training, Biomarkers
    Keywords
    Osteoarthritis, Knee, Exercise Training, Pain, Functional Status, Biomarkers, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Progressive Resistance Exercises Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Progresive Resistance Exercises
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    No intervation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Chair Stand Test
    Description
    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.
    Time Frame
    Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
    Title
    Timed Up and Go Test
    Description
    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.
    Time Frame
    Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
    Title
    Range of Motion
    Description
    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.
    Time Frame
    Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
    Title
    Muscle Strength
    Description
    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.
    Time Frame
    Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
    Title
    Serum Inflammatory Level
    Description
    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.
    Time Frame
    Blood collection will be done before treatment (week 0) and after treatment (week 13) to examine serum biomarker levels with ELISA kits.
    Title
    Visual Analogue Scale (VAS)
    Description
    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.
    Time Frame
    Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
    Title
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Description
    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.
    Time Frame
    Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
    Title
    Quality of Life Scale-Short Form (SF-12)
    Description
    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.
    Time Frame
    Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    meltem Meran Çağlar
    Phone
    05412210058
    Email
    meltem.meran@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meltem Meran Çağlar
    Organizational Affiliation
    Medipol University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    bayram ünver
    Organizational Affiliation
    Dokuz Eylul University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    eda merve kurtuluş
    Organizational Affiliation
    Istanbul Gelisim University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    mustafa tekkeşin
    Organizational Affiliation
    istanbul özel sondurak ümran tıp merkezi
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    It is aimed that the data obtained from the research will be published in an academic journal that can be seen and read by everyone, has open access, and is scanned in indexes. It is not aimed to publish in journals that have signed an embargo agreement. Moreover The method part of the academic publication to be produced from the data of our research will be written in detail so that the methods we applied in our research can be repeated by other clinicians or researchers.
    IPD Sharing Time Frame
    After the study is completed, the data of the study will not be presented in scientific journals and platforms that impose an embargo period that will restrict the sharing of data. Instead, it is aimed to publish scientific publications in high-quality scientific journals and platforms that offer open access.
    IPD Sharing Access Criteria
    It is aimed that the data obtained from the research will be published in an academic journal that can be seen and read by everyone, has open access, and is scanned in indexes. It is not aimed to publish in journals that have signed an embargo agreement. Moreover The method part of the academic publication to be produced from the data of our research will be written in detail so that the methods we applied in our research can be repeated by other clinicians or researchers.

    Learn more about this trial

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

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