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Clinical Trials/NCT06155227
NCT06155227
Not yet recruiting
Not Applicable

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

National Cheng Kung University1 site in 1 country60 target enrollmentDecember 20, 2023
ConditionsRehabilitation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rehabilitation
Sponsor
National Cheng Kung University
Enrollment
60
Locations
1
Primary Endpoint
Lower extremity muscle strength
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 20, 2023
End Date
December 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pei-Yun Lee

Associate Professor

National Cheng Kung University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Lower extremity muscle strength

Time Frame: At six weeks after completing the training

Use an hand-held dynamometer to measure bilateral lower limb muscle strength

Pulmonary function

Time Frame: At six weeks after completing the training

Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second

Timed up and go test

Time Frame: At six weeks after completing the training

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

Walking speed

Time Frame: At six weeks after completing the training

Test the gait speed under preferred and maximum speed walking

2 minutes step test

Time Frame: At six weeks after completing the training

Number of steps completed in 2 min

6 minutes walking test

Time Frame: At six weeks after completing the training

Record the distance walked in 6 minutes

Secondary Outcomes

  • Body composition(At six weeks after completing the training)

Study Sites (1)

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