Blood Flow Restriction Training in Pre-frail and Frail Older Adults

Sponsor
National Cheng Kung University (Other)
Overall Status
Completed
CT.gov ID
NCT04507152
Collaborator
(none)
26
1
2
15.7
1.7

Study Details

Study Description

Brief Summary

Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. However, blood flow restriction (BFR) training, a new resistance exercise training method, need merely lower resistance power and shorter training duration compared with traditional resistance exercise. Previous researches also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this study will test the effect of BFR training on muscle strength and functional performance in pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score between 3 to 5 will be recruited. Participants will be assigned to two groups using randomized block design with BFR training and control group. Structured questionnaire and physical function measurement will be used to assess the pre-intervention condition and outcome of different interventions. The participants will be assessed before training (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up at one and three months after training. Physical function measurement will include hand grip, muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and timed up and go test. Two-way repeated measures analysis of variance will be used to test the pre-test, 3-week, post-test and follow-ups difference between the two groups.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood flow restriction resistance training
  • Other: Resistance training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults
Actual Study Start Date :
Aug 5, 2020
Actual Primary Completion Date :
Nov 26, 2021
Actual Study Completion Date :
Nov 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Blood flow restriction resistance training

Other: Blood flow restriction resistance training
The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.

Active Comparator: Resistance training

Other: Resistance training
The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.

Outcome Measures

Primary Outcome Measures

  1. Change of muscle strength of the lower extremities [Before training, 3 and 6 weeks after training, and one and two months follow-ups]

    Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors

  2. Change of 30 seconds sit to stand [Before training, 3 and 6 weeks after training, and one and two months follow-ups]

    30 seconds sit to stand

  3. Change of timed-up-and-go test [Before training, 3 and 6 weeks after training, and one and two months follow-ups]

    Timed-up-and-go test

Secondary Outcome Measures

  1. Change of one-repetition maximum [Before training, 3 and 6 weeks after training, and one and two months follow-ups]

    One-repetition maximum of step-ups

  2. Change of muscle mass [Before training, 3 and 6 weeks after training, and one and two months follow-ups]

    Muscle mass of the upper and lower extremities and trunk

  3. Change of hand grip [Before training, 3 and 6 weeks after training, and one and two months follow-ups]

    Bilateral hand grip strength

  4. Change of physical activity level [Before training, 3 and 6 weeks after training, and one and two months follow-ups]

    The International Physical Activity Questionnaire (IPAQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Aged over 60 years old

  • Fried frailty index fulfill 1-2 criteria

  • Able to walk 6 meters independently

  • Able to understand and follow ≥ 3 instructions

Exclusion Criteria:
  • Severe hypertension (>180/110mmHg)

  • Peripheral neuropathy

  • History of deep-vein thrombosis (DVT)

  • Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis)

  • Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)

  • History of resisted exercise training program within the last 6 months before screening

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng Kung University Hospital Tainan city Taiwan

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, Assistant professor, National Cheng Kung University
ClinicalTrials.gov Identifier:
NCT04507152
Other Study ID Numbers:
  • A-BR-108-111-T
First Posted:
Aug 11, 2020
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
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, Assistant professor, National Cheng Kung University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022