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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209685
• Other study ID #: A-BR-110-075
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Therapy	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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