Blood Flow Restriction Training in Pre-frail and Frail Older Adults

NCT ID: NCT04507152

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-05
• Study Completion Date: 2021-11-26

Brief Summary

Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. However, blood flow restriction (BFR) training, a new resistance exercise training method, need merely lower resistance power and shorter training duration compared with traditional resistance exercise. Previous researches also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this study will test the effect of BFR training on muscle strength and functional performance in pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score between 3 to 5 will be recruited. Participants will be assigned to two groups using randomized block design with BFR training and control group. Structured questionnaire and physical function measurement will be used to assess the pre-intervention condition and outcome of different interventions. The participants will be assessed before training (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up at one and three months after training. Physical function measurement will include hand grip, muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and timed up and go test. Two-way repeated measures analysis of variance will be used to test the pre-test, 3-week, post-test and follow-ups difference between the two groups.

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Blood flow restriction resistance training

Group Type: EXPERIMENTAL

Blood flow restriction resistance training

Intervention Type: OTHER

The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.

Resistance training

Group Type: ACTIVE_COMPARATOR

Resistance training

Intervention Type: OTHER

The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.

Interventions

Blood flow restriction resistance training

The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.

Intervention Type: OTHER

Resistance training

The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged over 60 years old
• Fried frailty index fulfill 1-2 criteria
• Able to walk 6 meters independently
• Able to understand and follow ≥ 3 instructions

Exclusion Criteria

• Severe hypertension (>180/110mmHg)
• Peripheral neuropathy
• History of deep-vein thrombosis (DVT)
• Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis)
• Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)
• History of resisted exercise training program within the last 6 months before screening

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

Pei-Yun Lee

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

A-BR-108-111-T

Identifier Type: -

Identifier Source: org_study_id