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Clinical Trials/NCT04940702
NCT04940702UnknownNot Applicable

Effectiveness of Focal Vibration and Blood Flow Restriction Within a Multicomponent Exercise Programme for Non-dependent and Sedentary Elderly People. Effects on Biochemical Markers and Functional Tests. Pilot Study.

Universitat Internacional de Catalunya2 sites in 1 country30 target enrollmentStarted: February 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
2
Primary Endpoint
Biochemical markers (BLOOD TESTS)

Study Overview

Brief Summary

Sarcopenia can occur or increase due to sedentary lifestyles, physical inactivity or chronic endocrine and inflammatory disorders, this pathology is much more frequent in older people due to the added risk factors and the fact that the physiological ageing process generates a pro-inflammatory situation and an alteration in the synthesis of hormones and myokines, it has been observed that the loss of strength causes functional deterioration and a significant increase in the person's dependence, reduces their functional status and quality of life, and may increase the risk of falls, thereby increasing mortality.

Blood flow restriction (BRR) and focal vibration (FV), which aim to achieve muscular hypertrophy without the need to use high loads or intensities, VF or BFR brings improvements to elderly people with sarcopnoea.

The hipotesis of this study is the addition of BFR or VF techniques to training results in greater improvements in circulating myokine concentrations and functional tests than not adding it.

This study has the objective to determinate whether biochemical markers in serology are able to correlate with improvements in strength, also to study whether the plasma levels of apelin, myomyostatin and lL6 are modified with entraining, to determine whether plasma levels of apelin, myomyostatin and lL6 are further increased by training associated with VF and/or BFR and evaluate the effectiveness of different interventions in improving functional tests.

The methodology of the study is a single-blind, randomised, clinical trial will be conducted. The study population is people over 65 years of age, sedentary, with functional independence and with a state of health that allows them to carry out physical activity. The study is planned as a pilot study and will consist of 30 subjects distributed in: 10 people in the control group (CG), 10 in the experimental vibration group (GE-V) and 10 in the experimental group with restriction (GE-R).

The variables to be measured are anthropometric variables, biochemical markers, variables of neuromuscular function, information about fragility and independence, an functionality.

The intervention will be a training in the control group, the FV and BFR groups will be 3 times a week, with a warm-up, a main block with aerobic work, strength work and training and coordination work, and finally a return to calm, in the experimental groups the strength work will be carried out with these instruments.

Detailed Description

The normal ageing process is characterised by a progressive loss of muscle mass and function, this physiological process is known as sarcopenia. As a result of this loss of muscle mass and reduced efficiency of muscle enzymes, a reduction in overall strength and isometric strength in particular is observed. Secondarily, sarcopenia can occur or increase due to sedentary lifestyles, physical inactivity or chronic endocrine and inflammatory disorders. This pathology is much more frequent in older people due to the added risk factors and the fact that the physiological ageing process generates a pro-inflammatory situation and an alteration in the synthesis of hormones and myokines.

Different epidemiological studies show that maximum isometric voluntary contraction is usually maintained up to 45 years of age but its effectiveness decreases with age (25% at 65 years of age and 35% at 70 years of age). When this loss of strength or muscle mass occurs in the elderly with a baseline state of greater frailty or dependence, the clinical importance of this reduction in strength and muscle mass is much more relevant. It has been observed that the loss of strength causes functional deterioration and a significant increase in the person's dependence, reduces their functional status and quality of life, and may increase the risk of falls, thereby increasing mortality. For example, when hospital admissions occur, muscle mass decreases rapidly and in patients with femur fractures and sarcopenia it has been observed that between fracture and hospital discharge (10 days) the Barthel index decreases between 54.7% and 59.5%.

There does not seem to be a clear consensus on the diagnostic criteria for sarcopenia. Anthropometric parameters such as Skeletal Muscle Mass Index (SMMI) (≤8.87 for men and ≤6.42 for women), functional tests such as gait speed (≤0.8 metres/second) or grip strength (<30 or 20 kg for men and women respectively) are some of the most commonly used parameters in the literature for both diagnosis and monitoring of sarcopenia.

To a lesser extent, muscle cross-sectional area or contractile properties of muscle tissue could also be related to this loss of strength. More recently, and with the aim of confirming both the diagnosis and monitoring of sarcopenia, different biochemical markers have been proposed .

Regarding the treatment of sarcopenia, although there are pharmacological approaches to increase or maintain strength and muscle mass, physical activity and nutrition remain the "gold standard". Decreased physical activity level is a major aggravator of sarcopenia and sedentary lifestyles have been shown to result in accelerated loss of muscle mass, strength and functional capacity. Therefore, the American College of Sports Medicine, as well as recent research, shows that strength work at moderate to high load intensity can stimulate bone and muscle metabolism and improve overall strength, gait speed, quality of life, and reduce the risk of falls and cognitive impairment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 95 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Sedentary persons between 65 and 95 years of age.
  • Have a walking speed ≤0.8 metres per second as this is characteristic of patients with or with onset of sarcopenia.
  • Have a grip strength <30 kg for men and <20 kg for women as being characteristic of patients with or with onset of sarcopenia.

Exclusion Criteria

  • Severe untreated osteoporosis.
  • Having suffered a bone fracture in the last year.
  • Having had juvenile osteoporosis during adolescence or young adulthood.
  • Active chronic pathology
  • Uncontrolled arterial hypertension.
  • Uncontrolled orthostatic hypotension.
  • Severe acute respiratory failure.
  • Diabetes mellitus with acute decompensation or uncontrolled hypoglycaemia.
  • Endocrine, haematological and other associated rheumatic diseases.
  • Mental health problems (schizophrenia, dementia, depression, etc.) or not being in full mental capacity.
  • Patients with pharmacological treatments of glucocorticoids, anticoagulants and/or diuretics.
  • Patients with coagulation problems or previous cardiac pathology.
  • People with a body mass index (BMI) of 30 or more.
  • Subjects with a systemic disease or any other pathology in which therapeutic exercise may be contraindicated.

Outcomes

Primary Outcomes

Biochemical markers (BLOOD TESTS)

Time Frame: Change between baseline and post intervention

Apelin, myostatin, IL6, plasma proteins, uric acid and creatinine.

Secondary Outcomes

  • Fragility and independence (Barthel index)(Change between baseline and post intervention)
  • Physical Activity (PASE scale)(Change between baseline and post intervention)
  • Neuromuscular Function,Tensiomyography (Shrinkage time (Tc), and Radial displacement (Dm).(Change between baseline and post intervention)
  • Neuromuscular Function, Myotonometry (Stiffness)(Change between baseline and post intervention)
  • Neuromuscular Function, Surface electromyography: (% RMS)(Change between baseline and post intervention)
  • Neuromuscular Function, Manual Dinamometry. Pick force (kg)(Change between baseline and post intervention)
  • Neuromuscular Function, Handgrip (Kg)(Change between baseline and post intervention)
  • Neuromuscular Function, Stabilometry(Change between baseline and post intervention)
  • Neuromuscular Function, Ultrasound(Change between baseline and post intervention)
  • Fragility and independence (FRAIL scale)(Change between baseline and post intervention)
  • Fragility and independence (Falls Efficacy Scale I)(Change between baseline and post intervention)
  • Fragility and independence (SARC-F)(Change between baseline and post intervention)
  • Functionality (Short Physical Performance Battery)(Change between baseline and post intervention)
  • Functionality (Running speed in 4 metres)(Change between baseline and post intervention)
  • Functionality (Timed get up and go)(Change between baseline and post intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacobo Rodríguez Sanz

Principal Investigator

Universitat Internacional de Catalunya

Study Sites (2)

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