Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

Effect of Aerobic Exercise Combined With Blood Flow Restriction on Cardiopulmonary Function and Functional Activities in Frail Older Adults

Background:Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Exercise intervention including aerobic exercise training has been proven to be effective in improving aerobic capacity and frail condition in elderly. Recently a novel training method using blood flow restriction (BFR) combined with aerobic exercise has shown positive effects on muscles strength and physical function in healthy elderly. This training method only required lower exercise intensity compared with traditional aerobic exercise to observe improvement. However, it is still unclear whether aerobic exercise training combined with BFR could also improve aerobic capacity and physical function in frail older adults. Therefore, the aim of this study will be to investigate the effect of aerobic exercise combined with BFR on cardiopulmonary function and functional activities in frail older adults.

Method: This study will be an assessor-blind randomized controlled trial.Participants aged over 65 years old with more than one item positive of Fried frailty phenotype assessment results will be recruited from the hospital and nearby communities. The participants will be randomly assigned to one of two training groups, aerobic exercise with BFR and only aerobic exercise. The exercise will be executed 30 minutes/session, three sessions/week for six weeks. Cardiopulmonary function and performance of functional activities will be assessed at pre-training, 3 weeks after training, post-training, and 3- and 6-week follow-up.

Study Overview

• Status: Not yet recruiting
• Conditions: Rehabilitation
• Intervention / Treatment: Other: aerobic exercise combined with blood flow restriction; Other: aerobic exercise

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-Yun Lee, PhD; Phone Number: 5936 886-6-2353535; Email: peiyunlee@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan city, Taiwan, 701
    • Department of Physical Therapy
    • Contact: Pei-Yun Lee, PhD; Phone Number: 5936 886-6-235353; Email: peiyunlee@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• more than one positive item of Fried frailty phenotype assessment
• able to walk more than 8 meters independently
• can understand and follow more than three-step order

Exclusion Criteria:

• severe hypertension (>160/100 mmHg)
• cardiovascular disease, such as myocardial infarction, New York Heart Association class III or IV heart failure, pulmonary hypertension
• deep vein thrombosis or peripheral vascular disease
• peripheral neuropathy due to diabetes
• neuromuscular diseases, such as stroke, Parkinson's disease, etc.

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: Experimental Group	Other: aerobic exercise combined with blood flow restriction; aerobic exercise combined with blood flow restriction for 18 sessions
Active Comparator: Control Group	Other: aerobic exercise; aerobic exercise for 18 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	Before training
Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	After completing three-week training
Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	After completing six-week training
Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	At three weeks after completing the training
Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	At six weeks after completing the training
Pulmonary function	Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second	Before training
Pulmonary function	Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second	After completing three-week training
Pulmonary function	Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second	After completing six-week training
Pulmonary function	Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second	At three weeks after completing the training
Pulmonary function	Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second	At six weeks after completing the training
Timed up and go test	This test measures the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down	After completing three-week training
Timed up and go test	This test measures the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down	After completing six-week training
Timed up and go test	This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down	At three weeks after completing the training
Timed up and go test	This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down	At six weeks after completing the training
2 minutes step test	Number of steps completed in 2 min	Before training
2 minutes step test	Number of steps completed in 2 min	After completing three-week training
2 minutes step test	Number of steps completed in 2 min	After completing six-week training
2 minutes step test	Number of steps completed in 2 min	At three weeks after completing the training
2 minutes step test	Number of steps completed in 2 min	At six weeks after completing the training
6 minutes walking test	Record the distance walked in 6 minutes	Before training
6 minutes walking test	Record the distance walked in 6 minutes	After completing three-week training
6 minutes walking test	Record the distance walked in 6 minutes	After completing six-week training
6 minutes walking test	Record the distance walked in 6 minutes	At three weeks after completing the training
6 minutes walking test	Record the distance walked in 6 minutes	At six weeks after completing the training
Walking speed	Test the gait speed under preferred and maximum speed walking	Before training
Walking speed	Test the gait speed under preferred and maximum speed walking	After completing three-week training
Walking speed	Test the gait speed under preferred and maximum speed walking	After completing six-week training
Walking speed	Test the gait speed under preferred and maximum speed walking	At three weeks after completing the training
Walking speed	Test the gait speed under preferred and maximum speed walking	At six weeks after completing the training
Timed up and go test	This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down	Before training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities	Before training
Body composition	Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities	After completing six-week training
Body composition	Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities	At three weeks after completing the training
Body composition	Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities	At six weeks after completing the training

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Aerobic exercise; Frailty; Blood flow restriction
• Other Study ID Numbers: B-ER-112-370

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