Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

Sponsor
National Cheng Kung University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06155227
Collaborator
(none)
60
1
2
24
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: aerobic exercise combined with blood flow restriction
  • Other: aerobic exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Aerobic Exercise Combined With Blood Flow Restriction on Cardiopulmonary Function and Functional Activities in Frail Older Adults
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Lower extremity muscle strength [Before training]

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

  2. Lower extremity muscle strength [After completing three-week training]

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

  3. Lower extremity muscle strength [After completing six-week training]

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

  4. Lower extremity muscle strength [At three weeks after completing the training]

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

  5. Lower extremity muscle strength [At six weeks after completing the training]

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

  6. Pulmonary function [Before training]

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

  7. Pulmonary function [After completing three-week training]

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

  8. Pulmonary function [After completing six-week training]

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

  9. Pulmonary function [At three weeks after completing the training]

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

  10. Pulmonary function [At six weeks after completing the training]

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

  11. Timed up and go test [Before 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 downis to assess activity ability.

  12. Timed up and go test [After completing three-week training]

    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

  13. Timed up and go test [After completing six-week training]

    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

  14. Timed up and go test [At three 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

  15. Timed up and go test [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

  16. 2 minutes step test [Before training]

    Number of steps completed in 2 min

  17. 2 minutes step test [After completing three-week training]

    Number of steps completed in 2 min

  18. 2 minutes step test [After completing six-week training]

    Number of steps completed in 2 min

  19. 2 minutes step test [At three weeks after completing the training]

    Number of steps completed in 2 min

  20. 2 minutes step test [At six weeks after completing the training]

    Number of steps completed in 2 min

  21. 6 minutes walking test [Before training]

    Record the distance walked in 6 minutes

  22. 6 minutes walking test [After completing three-week training]

    Record the distance walked in 6 minutes

  23. 6 minutes walking test [After completing six-week training]

    Record the distance walked in 6 minutes

  24. 6 minutes walking test [At three weeks after completing the training]

    Record the distance walked in 6 minutes

  25. 6 minutes walking test [At six weeks after completing the training]

    Record the distance walked in 6 minutes

  26. Walking speed [Before training]

    Test the gait speed under preferred and maximum speed walking

  27. Walking speed [After completing three-week training]

    Test the gait speed under preferred and maximum speed walking

  28. Walking speed [After completing six-week training]

    Test the gait speed under preferred and maximum speed walking

  29. Walking speed [At three weeks after completing the training]

    Test the gait speed under preferred and maximum speed walking

  30. Walking speed [At six weeks after completing the training]

    Test the gait speed under preferred and maximum speed walking

Secondary Outcome Measures

  1. Body composition [Before training]

    Use Inbody 270 to measure skeletal muscle mass of the whold body and the four extremities

  2. Body composition [After completing six-week training]

    Use Inbody 270 to measure skeletal muscle mass of the whold body and the four extremities

  3. Body composition [At three weeks after completing the training]

    Use Inbody 270 to measure skeletal muscle mass of the whold body and the four extremities

  4. Body composition [At six weeks after completing the training]

    Use Inbody 270 to measure skeletal muscle mass of the whold body and the four extremities

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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-tep 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Physical Therapy Tainan city Taiwan 701

Sponsors and Collaborators

  • National Cheng Kung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pei-Yun Lee, Associate Professor, National Cheng Kung University
ClinicalTrials.gov Identifier:
NCT06155227
Other Study ID Numbers:
  • B-ER-112-370
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pei-Yun Lee, Associate Professor, National Cheng Kung University

Study Results

No Results Posted as of Dec 4, 2023