Clinical trial NCT05286723: Effectiveness Multicomponent Exercise Programme in Older Subjects. A Pilot Study.
Official title: Effectiveness Multicomponent Exercise Programme in Older Subjects. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Old Age; Debility
Sarcopenia
Exercise Addiction
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 13
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functionality (Running speed in 4 metres. Seconds)
timeFrame: Change between baseline and 6 weeks
measure: Functionality (Timed get up and go. Seconds)
timeFrame: Change between baseline and 6 weeks
Secondary outcomes:
measure: Functionality (Short Physical Performance Battery. 0-12 points)
timeFrame: Change between baseline and 6 weeks
measure: Neuromuscular Function, Handgrip (Kg)
timeFrame: Change between baseline and 6 weeks
measure: Neuromuscular Function, Myotonometry (Stiffness)
timeFrame: Change between baseline and 6 weeks
measure: Neuromuscular Function,Tensiomyography (Radial displacement (Dm)).
timeFrame: Change between baseline and 6 weeks
measure: Neuromuscular Function,Tensiomyography (Shrinkage time (Tc))
timeFrame: Change between baseline and 6 weeks
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References: