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Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05209685
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Pei-Yun Lee, National Cheng Kung University

Brief Summary:
This study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. It is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in pre-frail older adults.

Condition or disease Intervention/treatment Phase
Frailty Other: Resistance exercise on the lower extremities Other: Resistance exercise on the lower extremities with blood flow restriction Not Applicable

Detailed Description:
Participants aged over 65 years old with less than two items positive of Fried frailty phenotype assessment result will be recruited. The participants will be randomly assigned to two training groups, blood flow restriction resistance exercise and traditional resistance exercise. Both groups will receive the training 30 minutes/session, two sessions/week for six weeks. Muscle strength of the lower extremities and functional mobility tests will be used to assess outcomes at pre-training, 3-week after training, post-training, and one-month and two-month follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Blood Flow Restriction Resistance Exercise on Functional Mobility in Pre-Frail Older Adults
Estimated Study Start Date : January 19, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Resistance exercise with blood flow restriction
Other: Resistance exercise on the lower extremities with blood flow restriction
Blood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise.

Active Comparator: Control
Traditional resistance exercise
Other: Resistance exercise on the lower extremities
Resistance exercise mainly on the lower extremities will be executed by carrying weight according to each participant's tolerance while performing certain movements, such as side step-up, sit-to-stand, and tip-toe-standing.




Primary Outcome Measures :
  1. Change of Timed-Up and Go (TUG) test [ Time Frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention ]
    Timed-Up and Go test

  2. Change of 30 seconds sit to stand [ Time Frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention ]
    30 seconds sit to stand test

  3. Change of muscle strength of the lower extremities [ Time Frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention ]
    Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors


Secondary Outcome Measures :
  1. Change of one-repetition maximum [ Time Frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention ]
    One-repetiton maximum of side step-ups

  2. Change of muscle mass [ Time Frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention ]
    Muscle mass of the upper and lower extremities and trunk

  3. Change of hand grip strength [ Time Frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention ]
    Bilateral grip strength



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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged over 65 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209685


Contacts
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Contact: Pei-Yun Lee, PhD +886-6-2353535 ext 5936 peiyunlee@mail.ncku.edu.tw

Sponsors and Collaborators
National Cheng Kung University
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Responsible Party: Pei-Yun Lee, Associate professor, National Cheng Kung University
ClinicalTrials.gov Identifier: NCT05209685    
Other Study ID Numbers: A-BR-110-075
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pei-Yun Lee, National Cheng Kung University:
pre-frail, blood flow restriction, functional mobility
Additional relevant MeSH terms:
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Frailty
Pathologic Processes