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Completed

NCT Number: NCT05209685

Blood Flow Restriction 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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance exercise on the lower extremities

Other

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

Other

Blood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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