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

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

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.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Other: Resistance exercise on the lower extremities with blood flow restriction; Other: Resistance exercise on the lower extremities

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Timed-Up and Go (TUG) test	Timed-Up and Go test	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of 30 seconds sit to stand	30 seconds sit to stand test	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of muscle strength of the lower extremities	Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of one-repetition maximum	One-repetiton maximum of side step-ups	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of muscle mass	Muscle mass of the upper and lower extremities and trunk	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of hand grip strength	Bilateral grip strength	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pre-frail, blood flow restriction, functional mobility
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: A-BR-110-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No