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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507152
• Other study ID #: A-BR-108-111-T
• Status: Completed
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: November 26, 2021

Study information

• Verified date: January 2022
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 26, 2021
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan city

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Change of hand grip	Bilateral hand grip strength	Before training, 3 and 6 weeks after training, and one and two months follow-ups
Secondary	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