Old Age; DebilityNCT05286723
Effectiveness Multicomponent Exercise Programme in Older Subjects. A Pilot Study.
A study testing Multicomponent Training in people with Old Age; Debility and Sarcopenia, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Old Age; Debility, Sarcopenia, Exercise Addiction
- What is being tested?
- Multicomponent Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Albert Pérez-Bellmunt, PhD, 636817297, aperez@uic.es
About this 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.
Read more
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.
Read the 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.
- Conditions
- Old Age; Debility, Sarcopenia, Exercise Addiction
- Being tested
- Multicomponent Training
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent TrainingOther
Warm up, aerobic training, stenght training, balance and coordination training and return to calm
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Training | Experimental | Traditional training. 3 times a week
Warm-up:
Main work:
Aerobic training Strength training Balance and coordination training Return to calm Receives: Other: Multicomponent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change between baseline and 6 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Change between baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion15 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Rodríguez Sanz, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286723
- Sponsor's protocol ID
- CER202107B
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Multicomponent Exercise Programme in Older Subjects. A Pilot Study.
- ClinicalTrials.gov ID
- NCT05286723
- Acronym / sponsor ID
- CER202107B
- Conditions
- Old Age; Debility, Sarcopenia, Exercise Addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Training | Experimental | Other: Multicomponent TrainingTraditional training. 3 times a week Warm-up: Main work: Aerobic training Strength training Balance and coordination training Return to calm |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent TrainingWarm up, aerobic training, stenght training, balance and coordination training and return to calm | Other | Multicomponent Training |
Primary outcome
Functionality (Running speed in 4 metres. Seconds)
Time frame: Change between baseline and 6 weeks
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.
Functionality (Timed get up and go. Seconds)
Time frame: Change between baseline and 6 weeks
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.
5 secondary outcomes
Functionality (Short Physical Performance Battery. 0-12 points)
Time frame: Change between baseline and 6 weeks
Neuromuscular Function, Handgrip (Kg)
Time frame: Change between baseline and 6 weeks
Neuromuscular Function, Myotonometry (Stiffness)
Time frame: Change between baseline and 6 weeks
Neuromuscular Function,Tensiomyography (Radial displacement (Dm)).
Time frame: Change between baseline and 6 weeks
Neuromuscular Function,Tensiomyography (Shrinkage time (Tc))
Time frame: Change between baseline and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Training in people with Old Age; Debility and Sarcopenia, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacobo Rodríguez-Sanz, PhD (+34636136789, jrodriguezs@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality (Running speed in 4 metres. Seconds) (time frame: Change between baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.