Pre-frail ElderlyNCT03110419
Effects of a Multicomponent Training in Pre-frail Elderly
A study testing Physical Exercise in people with Pre-frail Elderly, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
This study aim to evaluate the effects of 16 weeks of multicomponent training on postural control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear and linear measurements. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-frail Elderly
- What is being tested?
- Physical Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2017to 10 Aug 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- >= 65 years old;
- conventional ECG without alterations in rest;
- medical release for physical exercise;
- understand the instructions and agree to participate.
Who cannot join
- historical stroke which produces loss of strength and aphasia;
- several impairment of motor skills;
- Parkinson disease;
- Diabetes Mellitus;
- Peripheral Neuropathy;
- Vestibular and visual disorders self-reported in anamnesis;
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- Severe cognitive impairment;
- Cardiovascular disorders (atrial fibrillation, malignant ventricular arrhythmia; ventricular beats complexes ectopic, sinus tachycardia or supraventricular, second and third degree of atrioventricular block, use of pacemaker in the resting ECG);
- Unstable angina;
- Myocardial infarction;
- Elderly end stage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Multicomponent Training on Postural Control and Cardiovascular and Musculoskeletal Systems in Pre-frail Elderly
This study aim to evaluate the effects of 16 weeks of multicomponent training on postural control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear and linear measurements.
Read the detailed description
Frailty syndrome is described as a clinical state of vulnerability to stress resulting from the decline of resilience and physiological reserves associated with aging. It is also characterized by a reduction of the interaction between systems and that would be reflected by a loss of physiological complexity. Physical exercise, especially the multi-component, is pointed out as a key element in the intervention of frail elderly individuals. However, it is still unclear whether the improvement in functional capacity observed with this type of training would be related to changes in the physiological complexity of these elderly individuals. The aim of this study is to evaluate the effect of multi-component training on the dynamics of the cardiovascular, motor, neuromuscular and physical activity levels of pre-frail elderly. Thirty-six pre-frail elderly individuals will be divided into intervention (IG, n = 18) and control (CG, n = 18) groups at three different moments (pre-intervention, post-intervention, 16 weeks, and follow-up of detraining of 6 Weeks). The complexity will be evaluated by calculating the entropy of the biological signals: a) heart rate, blood pressure (in supine and orthostatic conditions), b) oscillations of the pressure center (in open, closed eyes, after standing in a chair And under dual-task cognitive condition), c) torque oscillations of the knee extensor muscle group.
- Conditions
- Pre-frail Elderly
- Being tested
- Physical Exercise
- Keywords
- Elderly, Frailty, Multicomponent training, Physical exercise, Functional capacity, Complexity, Physical Therapy
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Also called Multicomponent exercise training
The intervention program will follow the recommendations of the American College of Sports Medicine (ACSM, 2009), including aerobic, muscle strength, flexibility and balance exercise. The duration of the intervention will be 16 weeks with sessions 60 min performed in three alternate days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The training group will perform a Physical Exercise as multicomponent training. Receives: Other: Physical Exercise |
| Control | No intervention | The control group will only be evaluated, without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear and nonlinear measurements of postural control
Sample Entropy; Approximate Entropy
Measured: Change from baseline sample entropy and approximate entropy at 16 weeks of multicomponent training and after 6 weeks of detraining
Linear and nonlinear measurements of cardiovascular system
Heart Rate Variability; Conditional Entropy
Measured: Change from baseline heart rate variability and conditional entropy at 16 weeks of multicomponent training and after 6 weeks of detraining
Linear and nonlinear measurements of musculoskeletal systems
Knee extensor torque complexity
Measured: Change from baseline knee extensor torque complexity at 16 weeks of multicomponent training and after 6 weeks of detraining
Cognition Measures
Addenbrooke's Cognitive Examination
Measured: Change from baseline addenbrooke's cognitive examination at 16 weeks of multicomponent training and after 6 weeks of detraining
Secondary outcomes (2)
Functional Measures
Six-minute Walk Test
Measured: Change from baseline six-minute walk test at 16 weeks of multicomponent training and after 6 weeks of detraining
Functional Measures
Short Physical Performance Battery
Measured: Change from baseline short physical performance battery at 16 weeks of multicomponent training and after 6 weeks of detraining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 May 2017
- Primary completion22 Jun 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-frail ElderlyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Anielle C M Takahashi, Universidade Federal de Sao Carlos
- Investigators
- Anielle CM Takahashi, PhD, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110419
- Sponsor's protocol ID
- LAPESI-02
- Status last verified
- Apr 2019
- First submitted
- 18 Aug 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carnavale BF, da Silva Santos VR, Farche ACS, Rossi PG, Fiogbe E, de Souza Buto MS, de Vassimon-Barroso V, de Medeiros Takahashi AC. Effects of a multicomponent training and detraining on frailty status, physical activity level, sedentary behavior patterns and physical performance of pre-frail older adults: a randomized controlled trial. Eur Geriatr Med. 2024 Dec;15(6):1701-1712. doi: 10.1007/s41999-024-01052-4. Epub 2024 Sep 11.
PubMed 39259383
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Training on Postural Control and Cardiovascular and Musculoskeletal Systems in Pre-frail Elderly
- ClinicalTrials.gov ID
- NCT03110419
- Acronym / sponsor ID
- LAPESI-02
- Conditions
- Pre-frail Elderly
- Keywords
- Elderly, Frailty, Multicomponent training, Physical exercise, Functional capacity, Complexity, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 May 2017 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 12 Apr 2017 (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.
This study aim to evaluate the effects of 16 weeks of multicomponent training on postural control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear and linear measurements.
Detailed description
Frailty syndrome is described as a clinical state of vulnerability to stress resulting from the decline of resilience and physiological reserves associated with aging. It is also characterized by a reduction of the interaction between systems and that would be reflected by a loss of physiological complexity. Physical exercise, especially the multi-component, is pointed out as a key element in the intervention of frail elderly individuals. However, it is still unclear whether the improvement in functional capacity observed with this type of training would be related to changes in the physiological complexity of these elderly individuals. The aim of this study is to evaluate the effect of multi-component training on the dynamics of the cardiovascular, motor, neuromuscular and physical activity levels of pre-frail elderly. Thirty-six pre-frail elderly individuals will be divided into intervention (IG, n = 18) and control (CG, n = 18) groups at three different moments (pre-intervention, post-intervention, 16 weeks, and follow-up of detraining of 6 Weeks). The complexity will be evaluated by calculating the entropy of the biological signals: a) heart rate, blood pressure (in supine and orthostatic conditions), b) oscillations of the pressure center (in open, closed eyes, after standing in a chair And under dual-task cognitive condition), c) torque oscillations of the knee extensor muscle group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Physical ExerciseThe training group will perform a Physical Exercise as multicomponent training. |
| Control | No intervention | –The control group will only be evaluated, without any intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- >= 65 years old;
- conventional ECG without alterations in rest;
- medical release for physical exercise;
- understand the instructions and agree to participate.
Key exclusion criteria (11 listed)
- historical stroke which produces loss of strength and aphasia;
- several impairment of motor skills;
- Parkinson disease;
- Diabetes Mellitus;
- Peripheral Neuropathy;
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 |
|---|---|---|
| Physical ExerciseAlso: Multicomponent exercise trainingThe intervention program will follow the recommendations of the American College of Sports Medicine (ACSM, 2009), including aerobic, muscle strength, flexibility and balance exercise. The duration of the intervention will be 16 weeks with sessions 60 min performed in three alternate days. | Other | Intervention |
Primary outcome
Linear and nonlinear measurements of postural control
Time frame: Change from baseline sample entropy and approximate entropy at 16 weeks of multicomponent training and after 6 weeks of detraining
Sample Entropy; Approximate Entropy
Linear and nonlinear measurements of cardiovascular system
Time frame: Change from baseline heart rate variability and conditional entropy at 16 weeks of multicomponent training and after 6 weeks of detraining
Heart Rate Variability; Conditional Entropy
Linear and nonlinear measurements of musculoskeletal systems
Time frame: Change from baseline knee extensor torque complexity at 16 weeks of multicomponent training and after 6 weeks of detraining
Knee extensor torque complexity
Cognition Measures
Time frame: Change from baseline addenbrooke's cognitive examination at 16 weeks of multicomponent training and after 6 weeks of detraining
Addenbrooke's Cognitive Examination
2 secondary outcomes
Functional Measures
Time frame: Change from baseline six-minute walk test at 16 weeks of multicomponent training and after 6 weeks of detraining
Functional Measures
Time frame: Change from baseline short physical performance battery at 16 weeks of multicomponent training and after 6 weeks of detraining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 39259383Carnavale BF, da Silva Santos VR, Farche ACS, Rossi PG, Fiogbe E, de Souza Buto MS, de Vassimon-Barroso V, de Medeiros Takahashi AC. Effects of a multicomponent training and detraining on frailty status, physical activity level, sedentary behavior patterns and physical performance of pre-frail older adults: a randomized controlled trial. Eur Geriatr Med. 2024 Dec;15(6):1701-1712. doi: 10.1007/s41999-024-01052-4. Epub 2024 Sep 11.
- Individual participant dataSharing planned: No
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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.
Anielle CM Takahashi, PhD principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise in people with Pre-frail Elderly, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 18 Apr 2019. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear and nonlinear measurements of postural control (time frame: Change from baseline sample entropy and approximate entropy at 16 weeks of multicomponent training and after 6 weeks of detraining). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03110419, which also lists 1 linked publication.
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 Apr 2019.