Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

NCT ID: NCT06155227

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2025-12-31

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.

Conditions

Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Group Type: EXPERIMENTAL

aerobic exercise combined with blood flow restriction

Intervention Type: OTHER

aerobic exercise combined with blood flow restriction for 18 sessions

Control Group

Group Type: ACTIVE_COMPARATOR

aerobic exercise

Intervention Type: OTHER

aerobic exercise for 18 sessions

Interventions

aerobic exercise combined with blood flow restriction

aerobic exercise combined with blood flow restriction for 18 sessions

Intervention Type: OTHER

aerobic exercise

aerobic exercise for 18 sessions

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

Pei-Yun Lee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Physical Therapy

Tainan City, , Taiwan

Countries

Taiwan

Central Contacts

Pei-Yun Lee, PhD

Role: CONTACT

peiyunlee@mail.ncku.edu.tw

886-6-2353535 ext. 5936

Facility Contacts

Pei-Yun Lee, PhD

Role: primary

peiyunlee@mail.ncku.edu.tw

886-6-235353 ext. 5936

Other Identifiers

B-ER-112-370

Identifier Type: -

Identifier Source: org_study_id