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Clinical Trials/NCT05209685
NCT05209685
Completed
Not Applicable

Effect of Blood Flow Restriction Resistance Exercise on Functional Mobility in Pre-Frail Older Adults

National Cheng Kung University1 site in 1 country54 target enrollmentAugust 17, 2020
ConditionsFrailty

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
National Cheng Kung University
Enrollment
54
Locations
1
Primary Endpoint
Change of 30 seconds sit to stand
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 17, 2020
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pei-Yun Lee

Associate professor

National Cheng Kung University

Eligibility 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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Change of muscle mass(Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention)
  • Change of one-repetition maximum(Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention)
  • Change of hand grip strength(Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention)

Study Sites (1)

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