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

Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Other: Blood flow restriction resistance training; Other: Resistance training

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan city, Taiwan
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood flow restriction resistance training	Other: 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.
Active Comparator: Resistance training	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of muscle strength of the lower extremities	Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors	Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of 30 seconds sit to stand	30 seconds sit to stand	Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of timed-up-and-go test	Timed-up-and-go test	Before training, 3 and 6 weeks after training, and one and two months follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of one-repetition maximum	One-repetition maximum of step-ups	Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of muscle mass	Muscle mass of the upper and lower extremities and trunk	Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of hand grip	Bilateral hand grip strength	Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of physical activity level	The International Physical Activity Questionnaire (IPAQ)	Before training, 3 and 6 weeks after training, and one and two months follow-ups

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Actual): November 26, 2021
• Study Completion (Actual): November 26, 2021

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Frailty; Resistance exercise; Blood flow restriction
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: A-BR-108-111-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No