Blood Flow Rextriction Training in Upper Extremity of Elderly

NCT ID: NCT05803733

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-09-10

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.

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.

Conditions

Exercise Training; Blood Flow Restriction Training; Geriatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Blood flow restriction (BFR) with low load resistance training

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.

Group Type: EXPERIMENTAL

Blood flow restriction (BFR) with low load resistance training

Intervention Type: OTHER

Combination of low load resistance exercise in the upper limb.

Routine strength training

Intervention Type: OTHER

range of motion exercises and strength training

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Routine strength training

Intervention Type: OTHER

range of motion exercises and strength training

Interventions

Blood flow restriction (BFR) with low load resistance training

Combination of low load resistance exercise in the upper limb.

Intervention Type: OTHER

Routine strength training

range of motion exercises and strength training

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medipol University

OTHER

Sponsor Role: collaborator

Bahçeşehir University

OTHER

Sponsor Role: collaborator

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

gizem ergezen

Gizem Ergezen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gizem Ergezen, PhD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Gizem Ergezen

Istanbul, Beykoz, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Gizem Ergezen, PhD

Role: CONTACT

gergezen@medipol.edu.tr

+902164448544 ext. 2470

Facility Contacts

Gizem Ergezen, MSc

Role: primary

gergezen@medipol.edu.tr

05347098414 ext. 2520

Other Identifiers

E-10840098-772.02-7706

Identifier Type: -

Identifier Source: org_study_id