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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia; Exercise Addiction; Old Age; Debility
• Intervention / Treatment: Other: Multicomponent Training

Detailed Description

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 variables to be measured are anthropometric variables such as height, sex, age, lower limb dominance and bioimpedance, we will also measure variables of neuromuscular function, with Tensiomyography: Contraction time (Tc), and radial displacement (Dm), Myotonometry: Stiffness, Surface electromyography: %RMS, all of this in muscles Rectus femoris, vastus lateralis, vastus medialis, lateral gastrocnemius and tibialis anterior. Manual dynamometry: Peak force (Kg) grip strength (Handgrip). Information on functionality with Short Physical Performance Battery (SPPB), velocity in 4 meters walking, Timed get up and go (TUG).

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.

The intervention will be a training 3 times a week with, warm up, articular and functional exercises with one's own body weight, principal work: Aerobic training 20 minutes waking then strenght training 25 minutes, i.Sets: start with 1 set to consolidate the technique, and progress to 3 sets.

ii.Repetitions: start with 10-15 repetitions (at lower intensity) and progress to 8-12 repetitions.

iii.Intensity: start with a lower intensity (even 20-30%1RM) and progress to 70-80%1RM.

iv.Rest: Breaks between sets of 3-5 minutes should be taken to avoid muscle fatigue.

v.Exercises: Leg press on machine Balance and co-ordination training during 5-10 minutes finally return to calm during 5 minutes with stretching.

• Study Type: Interventional
• Enrollment (Anticipated): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08195
      • Universitat Internacional de Catalunya
      • Contact: Albert Pérez-Bellmunt, PhD; Phone Number: 636817297; Email: aperez@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multicomponent Training; Traditional training. 3 times a week Warm-up: Main work: Aerobic training Strength training Balance and coordination training Return to calm	Other: Multicomponent Training; Warm up, aerobic training, stenght training, balance and coordination training and return to calm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality (Short Physical Performance Battery. 0-12 points)	It consists of a battery of three exercises with a maximum score of 4 points each. The first exercise assesses the participant's balance, the second exercise assesses walking speed and the third exercise assesses the strength of the lower limbs to stand up and sit down from the chair. The maximum SPPB score is 12 points indicating excellent functionality.	Change between baseline and 6 weeks
Neuromuscular Function, Handgrip (Kg)	A hand-held dynamometer shall be used to assess the maximum grip force for 5 seconds. The participant shall squeeze the dynamometer as hard as possible and the dynamometer shall record the force applied.	Change between baseline and 6 weeks
Neuromuscular Function, Myotonometry (Stiffness)	Myotonometry is an instrument that assesses the viscoelasticity of tissue by means of a mechanical impulse in the muscle belly. The device generates a small mechanical impulse in the muscle belly and, depending on the response of the muscle belly to this stimulus, provides the variable stiffness.	Change between baseline and 6 weeks
Neuromuscular Function,Tensiomyography (Radial displacement (Dm)).	Tensiomyography is an instrument which, at a given power, generates an involuntary muscle contraction in the muscle under examination. The contraction causes a movement of the muscle belly in a radial direction which is detected by a mechanical sensor placed just in contact with the muscle. The mechanical sensor collects the variables of radial displacement (Dm).	Change between baseline and 6 weeks
Neuromuscular Function,Tensiomyography (Shrinkage time (Tc))	Tensiomyography is an instrument which, at a given power, generates an involuntary muscle contraction in the muscle under examination. The contraction causes a movement of the muscle belly in a radial direction which is detected by a mechanical sensor placed just in contact with the muscle. The mechanical sensor collects the variables of contraction time (Tc).	Change between baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: CER202107B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No