NCT06155227

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

November 23, 2023

Last Update Submit

December 19, 2023

Conditions

Rehabilitation

Keywords

Blood flow restrictionAerobic exerciseFrailtyElderly

Outcome Measures

Primary Outcomes (30)

  • 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 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

  • 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

Secondary Outcomes (4)

  • Body composition

    Before training

  • Body composition

    After completing six-week training

  • Body composition

    At three weeks after completing the training

  • Body composition

    At six weeks after completing the training

Study Arms (2)

Experimental Group

EXPERIMENTAL
Other: aerobic exercise combined with blood flow restriction

Control Group

ACTIVE COMPARATOR
Other: aerobic exercise

Interventions

aerobic exercise combined with blood flow restrictionOTHER

aerobic exercise combined with blood flow restriction for 18 sessions

Experimental Group
aerobic exerciseOTHER

aerobic exercise for 18 sessions

Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Pei-Yun Lee, PhD

CONTACT

886-6-2353535peiyunlee@mail.ncku.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 4, 2023

Study Start

December 20, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)