Blood Flow Restriction in Older Adults. A Randomised Single-blind Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Change from baseline muscle power after treatment and at four weeks
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 80 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
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.
Intervention: Blood flow restriction training (Other)
Outcomes
Primary Outcomes
Change from baseline muscle power after treatment and at four weeks
Time Frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
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
Secondary Outcomes
- 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)
Investigators
Rubén Cuesta-Barriuso, PhD
Principal Investigator
University of Oviedo