Effectiveness Multicomponent Exercise Programme in Older Subjects. A Pilot Study.

NCT05286723 | Unknown

• 1 other identifier: CER202107B
• Study Type: interventional
• Target: 13
• 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. The hipotesis of this study is that multicomponent training 3 times a week for 6 weeks, produces improvements in the functional capacity of elderly patients. This study has the objective is whether multicomponent training 3 times a week for 6 weeks produces improvements in the functional capacity of elderly patients. The methodology is a pilot clinical trial. 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 13 subjects in the experimental group (multicomponent training). The variables to be measured are anthropometric variables and variables of neuromuscular function an functionality. The intervention will be a training will be 3 times a week during 6 weeks, with a warm-up, a main block with aerobic work, strength work and training and coordination work, and finally a return to calm.

Conditions

Old Age; Debility; Sarcopenia; Exercise Addiction

Outcome Measures

Primary Outcomes (2)

• Functionality (Running speed in 4 metres. Seconds)

  The participant's speed in covering 4 metres at their usual walking speed is assessed. The shorter the time, the faster the walking speed and therefore the better the functionality.

  Change between baseline and 6 weeks

• Functionality (Timed get up and go. Seconds)

  The time it takes the participant to get up from a chair, walk 3 metres, turn around an obstacle (a cone) and sit back down in the chair is assessed. The less time the participant takes to perform the test, the better the functionality.

  Change between baseline and 6 weeks

Secondary Outcomes (5)

• Functionality (Short Physical Performance Battery. 0-12 points)

  Change between baseline and 6 weeks

• Neuromuscular Function, Handgrip (Kg)

  Change between baseline and 6 weeks

• Neuromuscular Function, Myotonometry (Stiffness)

  Change between baseline and 6 weeks

• Neuromuscular Function,Tensiomyography (Radial displacement (Dm)).

  Change between baseline and 6 weeks

• Neuromuscular Function,Tensiomyography (Shrinkage time (Tc))

  Change between baseline and 6 weeks

Study Arms (1)

Multicomponent Training

EXPERIMENTAL

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

Other: Multicomponent Training

Interventions

Multicomponent Training OTHER

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

Multicomponent Training

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

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Central Study Contacts

Jacobo Rodríguez-Sanz, PhD

CONTACT

+34636136789; jrodriguezs@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 18, 2022
• Study Start: April 1, 2022
• Primary Completion: May 15, 2022
• Study Completion: June 1, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

ES (1)