Blood Flow Restriction in Older Adults

NCT06906523 | Active Not Recruiting

• 1 other identifier: Old-Rest
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction. From the age of 80 onwards, more than 50% of people suffer from sarcopenia. The loss of muscle strength leads to a loss of muscle power, impairing functionality and preventing the correct performance of activities of daily living. Objective. To analyse the efficacy of blood flow restriction in older adult patients by evaluating changes in the variables muscle power and strength, physical condition and functionality of the lower limbs. Material and method. Randomised single-blind clinical study. Thirty-six older adults will be recruited and randomised to the experimental and control groups. The intervention will have a duration of 4 weeks, with 2 weekly sessions. The intervention will consist of an intervention by performing 3 quadriceps strength exercises, with a 40% restriction. The primary variable of the study will be muscle power (Sit To Stand 5 times) and the secondary variables will be muscle strength (dynamometry), physical condition (Timed Up and Go) and functionality and autonomy (Barthel index)

Conditions

Older Patients

Keywords

Blood flow restriction; Older adults; Muscle power; Muscle strength; Functionality; Physical fitness

Outcome Measures

Primary Outcomes (1)

• Change from baseline muscle power after treatment and at four weeks

  Muscle power will be assessed with the Sit To Stand 5 times. This tool consists of getting up and sitting down from a chair five times. This instrument has shown high reliability (CCI= 0.95). The unit of measurement is time in seconds, where the shorter the time the greater the muscle power

  Screening visit, within the first seven days after treatment and four weeks follow-up visit

Secondary Outcomes (3)

• Change from baseline muscle strength after treatment and at four weeks

  Screening visit, within the first seven days after treatment and four weeks follow-up visit

• Change from baseline physical condition after treatment and at four weeks

  Screening visit, within the first seven days after treatment and four weeks follow-up visit

• Change from baseline functionality after treatment and at four weeks

  Screening visit, within the first seven days after treatment and four weeks follow-up visit

Study Arms (2)

Blood flow restriction

EXPERIMENTAL

An exercise protocol will be applied to work on lower limb strength in extension, with the application of BFR, with two 30-minute sessions per week for four weeks. The exercise protocol, based on previous studies in older adults, will consist of three exercises: climbing on a step, knee extension from a seated position and sitting down and getting up from a chair.

Other: Blood flow restriction training

No intervention

NO INTERVENTION

Patients included in the control group will not receive any intervention, maintaining their activities of daily living in the same way as before the study.

Interventions

Blood flow restriction training OTHER

The intensity of the work will be set at around 40% of the maximum intensity that can be executed in a single repetition (1RM). To reach the established intensity, weights, weighted ankle supports and rubber bands of different resistances will be used. Three sets of 8-10 repetitions will be performed with breaks of 1-2 seconds between repetitions and 2-3 minutes between sets. The intensity of the work will be established by applying the rate of perceived exertion. A blood flow restriction device will be used (Akrafit, Valencia, Spain model).

Blood flow restriction

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Older adults aged 65 to 80 years
• Independent for standing and walking with the help of assistive devices such as cane and walker
• Both genders
• Normotensive or hypertensive with controlled BP (systolic blood pressure \<140 mmHg)
• Sign the informed consent form.

You may not qualify if:

• People dependent for the performance of activities of daily living.
• People with cognitive impairments that limit the performance of the intervention or assessments.
• Persons undergoing total hip or knee arthroplasty
• Persons receiving physiotherapy treatment at the time of the study
• History of deep vein thrombosis (DVT) or pulmonary embolism
• History of myocardial infarction or stroke

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, Spain

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

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

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 2, 2025
• Study Start: March 12, 2025
• Primary Completion: April 13, 2025
• Study Completion: April 15, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)