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

Not Applicable

Completed

• Conditions: Frailty
• Interventions: Other: Resistance training; Other: Blood flow restriction resistance training

• Registration Number: NCT04507152
• Lead Sponsor: National Cheng Kung University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-04
• Study Start: 2020-08-05
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-11
• Primary Completion: 2021-11-26
• Study Completion: 2021-11-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance training	Resistance training	-
Blood flow restriction resistance training	Blood flow restriction resistance training	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan city, Taiwan