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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05803733
Other study ID # E-10840098-772.02-7706
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2023
Est. completion date September 10, 2023

Study information

Verified date July 2023
Source Istanbul Medipol University Hospital
Contact Gizem Ergezen, PhD
Phone +902164448544
Email gergezen@medipol.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Our study aims to decrease independence by increasing upper extremity strength and performance by applying blood flow restrictive training, which has entered the literature as a new method, to the upper extremity in the elderly. The application will only be applied to the upper extremity and will last for 6 weeks.


Description:

People are living longer now than in the past. The experience of old age in modern societies has gained importance with the prolongation of life expectancy. Over the years, the elderly lead to a decrease in physiological capacity and an increase in the risk of various diseases, resulting in a decrease in the functional capacity of the individual. Many physiological changes occur in the organism with advancing age. Muscle strength is an important determinant of healthy aging. It is known that the decrease in muscle mass and strength impairs body function and can have significant consequences for the individual, as well as increase economic costs. Impairment in function initially results in difficulties performing common daily activities such as carrying household items; however, when body strength falls below a clinically relevant threshold, mobility restriction increases and may affect independence in activities of basic daily living. Loss of independence requires support from caregivers; often leads to social withdrawal and adverse effects on well-being and quality of life. Muscle strength, function and mobility are the biggest determinants of independence. Handgrip strength is used in clinical practice, rehabilitation, and public health research to determine musculoskeletal function and assess frailty and disability. The aim of our study is to determine the effect of BFRT applied to the upper extremity for 6 weeks on general function, hand grip strength, upper extremity functional status, activities of daily living and functionality for elderly individuals between the ages of 65-75. Our hypothesis is that BFR will increase upper extremity function and related activities of daily living and mobility by increasing hand grip strength in elderly individuals.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 10, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 75 Years
Eligibility Inclusion Criteria: - Participants aged 65 and over who are classified as advanced age according to the World Health Organization - Volunteer basis Exclusion Criteria: - History of acute trauma to the hand or wrist - Scrapped upper extremity - Patients with symptoms of shoulder or elbow pain and rheumatoid arthritis, - Those who have participated in upper extremity weight training training in the last 6 months, - Those taking sedatives - Upper extremity venous thrombosis, - Being at high risk for cardiovascular conditions that interfere with exercise, unexplained chest pain or heart disease, fainting or dizziness during physical activity/exercise

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood flow restriction (BFR) with low load resistance training
Combination of low load resistance exercise in the upper limb.
Routine strength training
range of motion exercises and strength training

Locations

Country Name City State
Turkey Gizem Ergezen Istanbul Beykoz

Sponsors (3)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital Bahçesehir University, Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of Motion- ROM (shoulder flexion) The patient will be positioned in the supine position, with the arms next to the trunk and the elbow in extension. The pivot point of the goniometer will be placed on the greater tubercle of the humerus, the fixed arm will be placed parallel to the patient's axillary line, and the movable arm will be placed parallel to the lateral midline of the humerus. The patient will be asked to move his arm above his head without breaking his elbow, and the final angle will be recorded in degrees. Baseline
Primary Range of Motion- ROM (shoulder flexion) The patient will be positioned in the supine position, with the arms next to the trunk and the elbow in extension. The pivot point of the goniometer will be placed on the greater tubercle of the humerus, the fixed arm will be placed parallel to the patient's axillary line, and the movable arm will be placed parallel to the lateral midline of the humerus. The patient will be asked to move his arm above his head without breaking his elbow, and the final angle will be recorded in degrees. 6 weeks
Primary Range of Motion- ROM (shoulder flexion) The patient will be positioned in the supine position, with the arms next to the trunk and the elbow in extension. The pivot point of the goniometer will be placed on the greater tubercle of the humerus, the fixed arm will be placed parallel to the patient's axillary line, and the movable arm will be placed parallel to the lateral midline of the humerus. The patient will be asked to move his arm above his head without breaking his elbow, and the final angle will be recorded in degrees. 12 weeks
Primary Range of Motion - ROM (shoulder abduction) The patient will be positioned in the supine position, with the arms next to the trunk and the elbow in extension. The pivot point of the goniometer is placed on the acromion, the fixed arm is parallel to the sternum and the columna vertebralis, and the movable arm is placed parallel to the anterior midline of the humerus. The patient will be asked to move his arm by opening it from the side of the body without breaking his elbow, and the final angle will be recorded in degrees. Baseline
Primary Range of Motion - ROM (shoulder abduction) The patient will be positioned in the supine position, with the arms next to the trunk and the elbow in extension. The pivot point of the goniometer is placed on the acromion, the fixed arm is parallel to the sternum and the columna vertebralis, and the movable arm is placed parallel to the anterior midline of the humerus. The patient will be asked to move his arm by opening it from the side of the body without breaking his elbow, and the final angle will be recorded in degrees. 6 weeks
Primary Range of Motion - ROM (shoulder abduction) The patient will be positioned in the supine position, with the arms next to the trunk and the elbow in extension. The pivot point of the goniometer is placed on the acromion, the fixed arm is parallel to the sternum and the columna vertebralis, and the movable arm is placed parallel to the anterior midline of the humerus. The patient will be asked to move his arm by opening it from the side of the body without breaking his elbow, and the final angle will be recorded in degrees. 12 weeks
Primary Range of Motion - ROM (shoulder external rotation) The patient will be positioned in the supine position with the shoulder 90° abduction and the elbow 90° flexion. The pivot point of the goniometer will be placed in the olecranon, its fixed arm parallel to the ground at the edge of the measuring bed, and its movable arm parallel to the 3rd metacarpal. The patient will be asked to move the forearm in the direction of the thumb without lifting the elbow from the bed, and the last angle will be recorded in degrees. Baseline
Primary Range of Motion - ROM (shoulder external rotation) The patient will be positioned in the supine position with the shoulder 90° abduction and the elbow 90° flexion. The pivot point of the goniometer will be placed in the olecranon, its fixed arm parallel to the ground at the edge of the measuring bed, and its movable arm parallel to the 3rd metacarpal. The patient will be asked to move the forearm in the direction of the thumb without lifting the elbow from the bed, and the last angle will be recorded in degrees. 6 weeks
Primary Range of Motion - ROM (shoulder external rotation) The patient will be positioned in the supine position with the shoulder 90° abduction and the elbow 90° flexion. The pivot point of the goniometer will be placed in the olecranon, its fixed arm parallel to the ground at the edge of the measuring bed, and its movable arm parallel to the 3rd metacarpal. The patient will be asked to move the forearm in the direction of the thumb without lifting the elbow from the bed, and the last angle will be recorded in degrees. 12 weeks
Primary Range of Motion - ROM (shoulder internal rotation) The patient will be positioned in the supine position with the shoulder 90° abduction and the elbow 90° flexion. The pivot point, fixed arm and movable arm of the goniometer are positioned as in the shoulder external rotation measurement. The patient will be asked to move his forearm towards the bed in the direction of his little finger without lifting his elbow from the bed, and the last angle will be recorded in degrees. Baseline
Primary Range of Motion - ROM (shoulder internal rotation) The patient will be positioned in the supine position with the shoulder 90° abduction and the elbow 90° flexion. The pivot point, fixed arm and movable arm of the goniometer are positioned as in the shoulder external rotation measurement. The patient will be asked to move his forearm towards the bed in the direction of his little finger without lifting his elbow from the bed, and the last angle will be recorded in degrees. 6 weeks
Primary Range of Motion - ROM (shoulder internal rotation) The patient will be positioned in the supine position with the shoulder 90° abduction and the elbow 90° flexion. The pivot point, fixed arm and movable arm of the goniometer are positioned as in the shoulder external rotation measurement. The patient will be asked to move his forearm towards the bed in the direction of his little finger without lifting his elbow from the bed, and the last angle will be recorded in degrees. 12 weeks
Primary Grip strength grip strength It will be evaluated with the JAMAR™ isometric dynamometer (National Institute for Health Research, Southampton), a device recommended by the American Association of Hand Therapists (ASTH). The participant is seated in a chair without an armrest, feet flat on the floor, the shoulder is adducted with neutral rotation, the elbow is positioned at 90° flexion and the forearm is neutral. The JAMAR™ handle is worn in the second position, which allows for balanced activation of the intrinsic and extrinsic flexors of the fingers. 22 Perform three maximum repetitions on each side, starting with the dominant upper extremity. The average time to perform each attempt was determined as 5 seconds. During the test, the evaluator will encourage the generation and maintenance of power with a "stronger" verbal command. Finally, the average of the three measurements will be calculated and recorded. Baseline
Primary Grip strength It will be evaluated with the JAMAR™ isometric dynamometer (National Institute for Health Research, Southampton), a device recommended by the American Association of Hand Therapists (ASTH). The participant is seated in a chair without an armrest, feet flat on the floor, the shoulder is adducted with neutral rotation, the elbow is positioned at 90° flexion and the forearm is neutral. The JAMAR™ handle is worn in the second position, which allows for balanced activation of the intrinsic and extrinsic flexors of the fingers. 22 Perform three maximum repetitions on each side, starting with the dominant upper extremity. The average time to perform each attempt was determined as 5 seconds. During the test, the evaluator will encourage the generation and maintenance of power with a "stronger" verbal command. Finally, the average of the three measurements will be calculated and recorded. 6 weeks
Primary Grip strength It will be evaluated with the JAMAR™ isometric dynamometer (National Institute for Health Research, Southampton), a device recommended by the American Association of Hand Therapists (ASTH). The participant is seated in a chair without an armrest, feet flat on the floor, the shoulder is adducted with neutral rotation, the elbow is positioned at 90° flexion and the forearm is neutral. The JAMAR™ handle is worn in the second position, which allows for balanced activation of the intrinsic and extrinsic flexors of the fingers. 22 Perform three maximum repetitions on each side, starting with the dominant upper extremity. The average time to perform each attempt was determined as 5 seconds. During the test, the evaluator will encourage the generation and maintenance of power with a "stronger" verbal command. Finally, the average of the three measurements will be calculated and recorded. 12 weeks
Primary Pinch Strength The individual sits upright on the chair, adducts his shoulder close to his body, and flexes his elbow. For hand and finger grip strengths, one minute intervals are given between each measurement, three measurements are made and the averages are recorded. Measurements; When the individual is in a sitting position, the shoulder is in adduction and neutral rotation, the elbow is in 90 degrees flexion, the forearm is in neutral rotation and supported, and the wrist is in neutral, and it will be repeated 3 times with 30-second breaks. The average of 3 measurements will be taken as the result measurement. The key pinch method will be used in finger pinch strength measurement, and following this measurement, the patient's elbow will be brought to full extension and grip strength will be measured. Baseline
Primary Pinch Strength The individual sits upright on the chair, adducts his shoulder close to his body, and flexes his elbow. For hand and finger grip strengths, one minute intervals are given between each measurement, three measurements are made and the averages are recorded. Measurements; When the individual is in a sitting position, the shoulder is in adduction and neutral rotation, the elbow is in 90 degrees flexion, the forearm is in neutral rotation and supported, and the wrist is in neutral, and it will be repeated 3 times with 30-second breaks. The average of 3 measurements will be taken as the result measurement. The key pinch method will be used in finger pinch strength measurement, and following this measurement, the patient's elbow will be brought to full extension and grip strength will be measured. 6 weeks
Primary Pinch Strength The individual sits upright on the chair, adducts his shoulder close to his body, and flexes his elbow. For hand and finger grip strengths, one minute intervals are given between each measurement, three measurements are made and the averages are recorded. Measurements; When the individual is in a sitting position, the shoulder is in adduction and neutral rotation, the elbow is in 90 degrees flexion, the forearm is in neutral rotation and supported, and the wrist is in neutral, and it will be repeated 3 times with 30-second breaks. The average of 3 measurements will be taken as the result measurement. The key pinch method will be used in finger pinch strength measurement, and following this measurement, the patient's elbow will be brought to full extension and grip strength will be measured. 12 weeks
Primary Daily Living Activities The modified Barthel Activities of Daily Living scale is a questionnaire that measures nutrition, transfer, self-care, sitting on the toilet, washing, walking on a smooth surface, going up and down stairs, dressing, bowel care, and bladder care. The activities are scored according to the degree of ability of the person and the total score determines the degree of addiction. Baseline
Primary Daily Living Activities The modified Barthel Activities of Daily Living scale is a questionnaire that measures nutrition, transfer, self-care, sitting on the toilet, washing, walking on a smooth surface, going up and down stairs, dressing, bowel care, and bladder care. The activities are scored according to the degree of ability of the person and the total score determines the degree of addiction. 6 week
Primary Daily Living Activities The modified Barthel Activities of Daily Living scale is a questionnaire that measures nutrition, transfer, self-care, sitting on the toilet, washing, walking on a smooth surface, going up and down stairs, dressing, bowel care, and bladder care. The activities are scored according to the degree of ability of the person and the total score determines the degree of addiction. 12 week
Primary Function Timed up and go test: Participants will perform certain sequences of movements: getting up from a chair (41 cm height with back support), walking three meters, turning, walking back to the chair, and sitting again. The test will be performed three times and the shortest time (in seconds) will be used for analysis. Baseline
Primary Function Timed up and go test: Participants will perform certain sequences of movements: getting up from a chair (41 cm height with back support), walking three meters, turning, walking back to the chair, and sitting again. The test will be performed three times and the shortest time (in seconds) will be used for analysis. 6 week
Primary Function Timed up and go test: Participants will perform certain sequences of movements: getting up from a chair (41 cm height with back support), walking three meters, turning, walking back to the chair, and sitting again. The test will be performed three times and the shortest time (in seconds) will be used for analysis. 12 week
Primary Function (upper extremity) It consists of 11 items from a 30-item DASH questionnaire designed to assess symptoms and physical and social functions related to upper extremity complaints. Each item is scored on a 1 to 5 scale; A final score between 0 and 100 where 1 indicates "no difficulty" and 5 indicates "extreme difficulty", and a maximum score indicates greater upper extremity dysfunction. Baseline
Primary Function (upper extremity) It consists of 11 items from a 30-item DASH questionnaire designed to assess symptoms and physical and social functions related to upper extremity complaints. Each item is scored on a 1 to 5 scale; A final score between 0 and 100 where 1 indicates "no difficulty" and 5 indicates "extreme difficulty", and a maximum score indicates greater upper extremity dysfunction. 6 weeks
Primary Function (upper extremity) It consists of 11 items from a 30-item DASH questionnaire designed to assess symptoms and physical and social functions related to upper extremity complaints. Each item is scored on a 1 to 5 scale; A final score between 0 and 100 where 1 indicates "no difficulty" and 5 indicates "extreme difficulty", and a maximum score indicates greater upper extremity dysfunction. 12 weeks
Secondary Balance Berg Balance Scale: The scale includes 14 increasingly difficult tasks, including changing body position, maintaining a sitting position, maintaining a standing position with and without visual control, standing in a tandem position, standing on one leg, pivoting, reaching forward, lifting objects. Baseline
Secondary Balance Berg Balance Scale: The scale includes 14 increasingly difficult tasks, including changing body position, maintaining a sitting position, maintaining a standing position with and without visual control, standing in a tandem position, standing on one leg, pivoting, reaching forward, lifting objects. 6 weeks
Secondary Balance Berg Balance Scale: The scale includes 14 increasingly difficult tasks, including changing body position, maintaining a sitting position, maintaining a standing position with and without visual control, standing in a tandem position, standing on one leg, pivoting, reaching forward, lifting objects. 12 weeks
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