Exercise TrainingNCT05803733
Blood Flow Rextriction Training in Upper Extremity of Elderly
A study testing Blood flow restriction (BFR) with low load resistance training and Routine strength training in people with Exercise Training and Blood Flow Restriction Training, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Blood Flow Restriction Training, Geriatrics
- What is being tested?
- Blood flow restriction (BFR) with low load resistance training and Routine strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 10 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants aged 65 and over who are classified as advanced age according to the World Health Organization
- Volunteer basis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gizem Ergezen
Istanbul, Beykoz, 34810
Gizem Ergezen, MSc, 05347098414 ext. 2520, gergezen@medipol.edu.tr
Gizem Ergezen, MSc
About this study
Official title: The Effect of Blood Flow Restrictive Exercise on Grip Strength and Upper Extremity Functions in Elderly Individuals
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.
Read the 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.
- Being tested
- Blood flow restriction (BFR) with low load resistance training, Routine strength training
- Keywords
- Blood Flow Restriction Training, geriatrics, performance, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction (BFR) with low load resistance trainingOther
Combination of low load resistance exercise in the upper limb.
Routine strength trainingOther
range of motion exercises and strength training
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction (BFR) with low load resistance training | Experimental | Participants will have the routine rehabilitation protocol and as an addition 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 BP in the arm during rest and increased to 60%. 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. 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. Receives: Other: Blood flow restriction (BFR) with low load resistance training; Other: Routine strength training |
| Control Group | Active comparator | Participants only will have the rehabilitation protocol including general physiotherapeutic approaches such as range of motion exercises and strength training which is a daily part of their nursing home services. Receives: Other: Routine strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: 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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: Baseline
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.
Measured: 6 week
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.
Measured: 12 week
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.
Measured: Baseline
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.
Measured: 6 week
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.
Measured: 12 week
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Feb 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University, Bahçeşehir University
- Responsible party
- Principal investigator, gizem ergezen, Istanbul Medipol University Hospital
- Investigators
- Gizem Ergezen, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803733
- Sponsor's protocol ID
- E-10840098-772.02-7706
- Status last verified
- Jul 2023
- First submitted
- 27 Mar 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restrictive Exercise on Grip Strength and Upper Extremity Functions in Elderly Individuals
- ClinicalTrials.gov ID
- NCT05803733
- Acronym / sponsor ID
- E-10840098-772.02-7706
- Keywords
- Blood Flow Restriction Training, geriatrics, performance, muscle strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Medipol University, Bahçeşehir University
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction (BFR) with low load resistance training | Experimental | Other: Blood flow restriction (BFR) with low load resistance training, Other: Routine strength trainingParticipants will have the routine rehabilitation protocol and as an addition 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 BP in the arm during rest and increased to 60%. 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. 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. |
| Control Group | Active comparator | Other: Routine strength trainingParticipants only will have the rehabilitation protocol including general physiotherapeutic approaches such as range of motion exercises and strength training which is a daily part of their nursing home services. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Participants aged 65 and over who are classified as advanced age according to the World Health Organization
- Volunteer basis
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction (BFR) with low load resistance trainingCombination of low load resistance exercise in the upper limb. | Other | Blood flow restriction (BFR) with low load resistance training |
| Routine strength trainingrange of motion exercises and strength training | Other | Blood flow restriction (BFR) with low load resistance training, Control Group |
Primary outcome
Range of Motion- ROM (shoulder flexion)
Time frame: 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.
Range of Motion- ROM (shoulder flexion)
Time frame: 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.
Range of Motion- ROM (shoulder flexion)
Time frame: 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.
Range of Motion - ROM (shoulder abduction)
Time frame: 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.
Range of Motion - ROM (shoulder abduction)
Time frame: 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.
Range of Motion - ROM (shoulder abduction)
Time frame: 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.
Range of Motion - ROM (shoulder external rotation)
Time frame: 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.
Range of Motion - ROM (shoulder external rotation)
Time frame: 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.
Range of Motion - ROM (shoulder external rotation)
Time frame: 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.
Range of Motion - ROM (shoulder internal rotation)
Time frame: 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.
Range of Motion - ROM (shoulder internal rotation)
Time frame: 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.
Range of Motion - ROM (shoulder internal rotation)
Time frame: 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.
Grip strength
Time frame: 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.
Grip strength
Time frame: 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.
Grip strength
Time frame: 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.
Pinch Strength
Time frame: 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.
Pinch Strength
Time frame: 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.
Pinch Strength
Time frame: 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.
Daily Living Activities
Time frame: 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.
Daily Living Activities
Time frame: 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.
Daily Living Activities
Time frame: 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.
Function
Time frame: 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.
Function
Time frame: 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.
Function
Time frame: 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.
Function (upper extremity)
Time frame: 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.
Function (upper extremity)
Time frame: 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.
Function (upper extremity)
Time frame: 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.
3 secondary outcomes
Balance
Time frame: Baseline
Balance
Time frame: 6 weeks
Balance
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Ergezen, PhD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction (BFR) with low load resistance training and Routine strength training in people with Exercise Training and Blood Flow Restriction Training, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gizem Ergezen, PhD (+902164448544 ext. 2470, gergezen@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion- ROM (shoulder flexion) (time frame: Baseline). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.