Back to resultsBlood Flow Restriction on Functional Mobility in Pre-frail Older Adults
Primary Purpose
Frailty
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistance exercise on the lower extremities
Resistance exercise on the lower extremities with blood flow restriction
Sponsored by
About this trial
This is an interventional treatment trial for Frailty focused on measuring pre-frail, blood flow restriction, functional mobility
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Resistance exercise with blood flow restriction
Traditional resistance exercise
Outcomes
Primary Outcome Measures
Change of Timed-Up and Go (TUG) test
Timed-Up and Go test
Change of 30 seconds sit to stand
30 seconds sit to stand test
Change of muscle strength of the lower extremities
Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors
Secondary Outcome Measures
Change of one-repetition maximum
One-repetiton maximum of side step-ups
Change of muscle mass
Muscle mass of the upper and lower extremities and trunk
Change of hand grip strength
Bilateral grip strength
Full Information
NCT ID
NCT05209685
First Posted
January 10, 2022
Last Updated
January 25, 2022
Sponsor
National Cheng Kung University
1. Study Identification
Unique Protocol Identification Number
NCT05209685
Brief Title
Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults
Official Title
Effect of Blood Flow Restriction Resistance Exercise on Functional Mobility in Pre-Frail Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 19, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
pre-frail, blood flow restriction, functional mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Resistance exercise with blood flow restriction
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Traditional resistance exercise
Intervention Type
Other
Intervention Name(s)
Resistance exercise on the lower extremities
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance exercise on the lower extremities with blood flow restriction
Intervention Description
Blood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise.
Primary Outcome Measure Information:
Title
Change of Timed-Up and Go (TUG) test
Description
Timed-Up and Go test
Time Frame
Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Title
Change of 30 seconds sit to stand
Description
30 seconds sit to stand test
Time Frame
Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Title
Change of muscle strength of the lower extremities
Description
Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors
Time Frame
Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Secondary Outcome Measure Information:
Title
Change of one-repetition maximum
Description
One-repetiton maximum of side step-ups
Time Frame
Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Title
Change of muscle mass
Description
Muscle mass of the upper and lower extremities and trunk
Time Frame
Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Title
Change of hand grip strength
Description
Bilateral grip strength
Time Frame
Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Yun Lee, PhD
Phone
+886-6-2353535
Ext
5936
Email
peiyunlee@mail.ncku.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults
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