Blood Flow Restriction Training in Pre-frail and Frail Older Adults

NCT04507152 | Completed

• 1 other identifier: A-BR-108-111-T
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. However, blood flow restriction (BFR) training, a new resistance exercise training method, need merely lower resistance power and shorter training duration compared with traditional resistance exercise. Previous researches also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this study will test the effect of BFR training on muscle strength and functional performance in pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score between 3 to 5 will be recruited. Participants will be assigned to two groups using randomized block design with BFR training and control group. Structured questionnaire and physical function measurement will be used to assess the pre-intervention condition and outcome of different interventions. The participants will be assessed before training (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up at one and three months after training. Physical function measurement will include hand grip, muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and timed up and go test. Two-way repeated measures analysis of variance will be used to test the pre-test, 3-week, post-test and follow-ups difference between the two groups.

Conditions

Frailty

Keywords

Blood flow restriction; Resistance exercise; Frailty

Outcome Measures

Primary Outcomes (3)

• Change of muscle strength of the lower extremities

  Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors

  Before training, 3 and 6 weeks after training, and one and two months follow-ups

• Change of 30 seconds sit to stand

  30 seconds sit to stand

  Before training, 3 and 6 weeks after training, and one and two months follow-ups

• Change of timed-up-and-go test

  Timed-up-and-go test

  Before training, 3 and 6 weeks after training, and one and two months follow-ups

Secondary Outcomes (4)

• Change of one-repetition maximum

  Before training, 3 and 6 weeks after training, and one and two months follow-ups

• Change of muscle mass

  Before training, 3 and 6 weeks after training, and one and two months follow-ups

• Change of hand grip

  Before training, 3 and 6 weeks after training, and one and two months follow-ups

• Change of physical activity level

  Before training, 3 and 6 weeks after training, and one and two months follow-ups

Study Arms (2)

Blood flow restriction resistance training

EXPERIMENTAL

Other: Blood flow restriction resistance training

Resistance training

ACTIVE COMPARATOR

Other: Resistance training

Interventions

Blood flow restriction resistance training OTHER

The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.

Blood flow restriction resistance training

Resistance training OTHER

The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.

Resistance training

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 60 years old
• Fried frailty index fulfill 1-2 criteria
• Able to walk 6 meters independently
• Able to understand and follow ≥ 3 instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Frailty

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 11, 2020
• Study Start: August 5, 2020
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)