Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06155227
• Other study ID #: B-ER-112-370
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: National Cheng Kung University
• Contact: Pei-Yun Lee, PhD
• Phone: 886-6-2353535
• Email: peiyunlee[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Other:
• aerobic exercise combined with blood flow restriction
aerobic exercise combined with blood flow restriction for 18 sessions
• aerobic exercise
aerobic exercise for 18 sessions

Locations

Country	Name	City	State
Taiwan	Department of Physical Therapy	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	Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	Before training
Primary	Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	After completing three-week training
Primary	Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	After completing six-week training
Primary	Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	At three weeks after completing the training
Primary	Lower extremity muscle strength	Use an hand-held dynamometer to measure bilateral lower limb muscle strength	At six weeks after completing the training
Primary	Pulmonary function	Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second	Before training
Primary	Pulmonary function	Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second	After completing three-week training
Primary	Pulmonary function	Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second	After completing six-week training
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	2 minutes step test	Number of steps completed in 2 min	Before training
Primary	2 minutes step test	Number of steps completed in 2 min	After completing three-week training
Primary	2 minutes step test	Number of steps completed in 2 min	After completing six-week training
Primary	2 minutes step test	Number of steps completed in 2 min	At three weeks after completing the training
Primary	2 minutes step test	Number of steps completed in 2 min	At six weeks after completing the training
Primary	6 minutes walking test	Record the distance walked in 6 minutes	Before training
Primary	6 minutes walking test	Record the distance walked in 6 minutes	After completing three-week training
Primary	6 minutes walking test	Record the distance walked in 6 minutes	After completing six-week training
Primary	6 minutes walking test	Record the distance walked in 6 minutes	At three weeks after completing the training
Primary	6 minutes walking test	Record the distance walked in 6 minutes	At six weeks after completing the training
Primary	Walking speed	Test the gait speed under preferred and maximum speed walking	Before training
Primary	Walking speed	Test the gait speed under preferred and maximum speed walking	After completing three-week training
Primary	Walking speed	Test the gait speed under preferred and maximum speed walking	After completing six-week training
Primary	Walking speed	Test the gait speed under preferred and maximum speed walking	At three weeks after completing the training
Primary	Walking speed	Test the gait speed under preferred and maximum speed walking	At six weeks after completing the training
Secondary	Body composition	Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities	Before training
Secondary	Body composition	Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities	After completing six-week training
Secondary	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
Secondary	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