Effectiveness of Focal Vibration and Blood Flow Restriction Within a Multicomponent Exercise Programme.

NCT04940702 | Unknown

• 1 other identifier: CER202107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Occlusion; Vibration; Exposure; Old Age; Atrophy; Exercise Addiction

Outcome Measures

Primary Outcomes (1)

• Biochemical markers (BLOOD TESTS)

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

  Change between baseline and post intervention

Secondary Outcomes (15)

• 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

Study Arms (3)

Focal Vibration Group

EXPERIMENTAL

Training with Focal Vibration on rectus anterior, vastus medialis and vastus lateralis muscles with an intensity of 120 Hz and an amplitude of 1.2 mm. Time of training 20-25 min. the training is the same as the contol group with the difference of FV addiction.

Other: Focal Vibration

Blood Flow Restriction Group

ACTIVE COMPARATOR

Training with Blood Flow Restriction a pressure cuff occludes in the proximal part of the lower limb. Time of training 20-25 min. the training is the same as the contol group with the difference of BFR addiction.

Other: Blood Flow Restriction

Training Group

ACTIVE COMPARATOR

Traditional training. 3 times a week 1. Warm-up: 2. Main work: 1. Aerobic training 2. Strength training 3. Balance and coordination training 3. Return to calm

Other: Traditional Training

Interventions

Focal Vibration OTHER

Training with Focal Vibration on rectus anterior, vastus medialis and vastus lateralis muscles with an intensity of 120 Hz and an amplitude of 1.2 mm. Time of training 20-25 min. The exercise is the same than traditional training group.

Focal Vibration Group

Blood Flow Restriction OTHER

Training with Blood Flow Restriction, the restriction is in the proximal part of the lower limb. The exercise is the same than traditional training group.

Blood Flow Restriction Group

Traditional Training OTHER

Warm up, aerobic training, stenght training, balance and coordination training and return to calm

Training Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Sarcopenia; Bites and Stings; Atrophy

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Jacobo Rodríguez-Sanz, Dr

CONTACT

636136789; jrodriguezs@uic.es

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: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 25, 2021
• Study Start: February 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: September 1, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-06

Locations

ES (1)