Blood Flow Restriction in Older Adults

NCT ID: NCT06906523

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-04-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Blood flow restriction

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.

Group Type: EXPERIMENTAL

Blood flow restriction training

Intervention Type: 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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Blood flow restriction training

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Rubén Cuesta-Barriuso, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Católica San Antonio de Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

Old-Rest

Identifier Type: -

Identifier Source: org_study_id