Blood Flow Rextriction Training in Upper Extremity of Elderly

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05803733
Collaborator
Medipol University (Other), Bahçeşehir University (Other)
30
1
1
2.8
10.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood flow restriction (BFR) with low load resistance training
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Blood Flow Restrictive Exercise on Grip Strength and Upper Extremity Functions in Elderly Individuals
Actual Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Blood flow restriction (BFR) with low load resistance training

Participants will use a cuff placed proximal to the arm during upper extremity strengthening exercises. The cuff to be used is 175mm wide and 920mm long. After the cuff is placed, it will be inflated to the determined arterial occlusion pressure. The pressure will be adjusted to 50% of the blood pressure in the arm during rest and will be increased to 60% in the 2nd set. Exercises will be performed with the cuff inflated, at approximately 20-30% of 1RM. The first set will be 30 repetitions or at the limit of fatigue (maximum of 4/10), then three sets of 15 repetitions. The cuff will not be deflated for the 30 second rest between sets. All exercises will be performed at the border of pain, the load will be reduced by 20% in the presence of high-intensity pain. A rehabilitation session will be held under the supervision of a physiotherapist. Exercise will be performed for 6 weeks with 3 sessions each week, with 1-2 days break between sessions.

Other: Blood flow restriction (BFR) with low load resistance training
Combination of low load resistance exercise in the upper limb.

Outcome Measures

Primary Outcome Measures

  1. Range of Motion- ROM (shoulder flexion) [Baseline]

    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.

  2. Range of Motion- ROM (shoulder flexion) [6 weeks]

    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.

  3. Range of Motion- ROM (shoulder flexion) [12 weeks]

    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.

  4. Range of Motion - ROM (shoulder abduction) [Baseline]

    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.

  5. Range of Motion - ROM (shoulder abduction) [6 weeks]

    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. Range of Motion - ROM (shoulder abduction) [12 weeks]

    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.

  7. Range of Motion - ROM (shoulder external rotation) [Baseline]

    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.

  8. Range of Motion - ROM (shoulder external rotation) [6 weeks]

    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.

  9. Range of Motion - ROM (shoulder external rotation) [12 weeks]

    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.

  10. Range of Motion - ROM (shoulder internal rotation) [Baseline]

    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.

  11. Range of Motion - ROM (shoulder internal rotation) [6 weeks]

    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. Range of Motion - ROM (shoulder internal rotation) [12 weeks]

    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.

  13. Grip strength [Baseline]

    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.

  14. Grip strength [6 weeks]

    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.

  15. Grip strength [12 weeks]

    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.

  16. Pinch Strength [Baseline]

    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.

  17. Pinch Strength [6 weeks]

    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.

  18. Pinch Strength [12 weeks]

    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.

  19. Daily Living Activities [Baseline]

    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.

  20. Daily Living Activities [6 week]

    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.

  21. Daily Living Activities [12 week]

    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.

  22. Function [Baseline]

    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.

  23. Function [6 week]

    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.

  24. Function [12 week]

    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.

  25. Function (upper extremity) [Baseline]

    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.

  26. Function (upper extremity) [6 weeks]

    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.

  27. Function (upper extremity) [12 weeks]

    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.

Secondary Outcome Measures

  1. Balance [Baseline]

    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.

  2. Balance [6 weeks]

    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.

  3. Balance [12 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gizem Ergezen Istanbul Beykoz Turkey 34810

Sponsors and Collaborators

  • Istanbul Medipol University Hospital
  • Medipol University
  • Bahçeşehir University

Investigators

  • Principal Investigator: Gizem Ergezen, PhD, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05803733
Other Study ID Numbers:
  • E-10840098-772.02-7706
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istanbul Medipol University Hospital

Study Results

No Results Posted as of Apr 7, 2023