Older PeopleNCT07152158
Multicomponent Training Combined With Multi-professional Intervention Health Status in Hypertensive and Normotensive Older Women
A study testing multicomponent training combined with multi-professional intervention in people with Older People, run by Universidad Católica del Maule at 1 site in Chile.
Trial summary
Objective: The objective of this study was to analyze the effects of multicomponent training (MCT) combined with multidisciplinary intervention (nutritional and psychoeducation) on body composition, biochemical markers, and physical performance in hypertensive and normotensive older women. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Older People
- What is being tested?
- multicomponent training combined with multi-professional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChile
- Study dates
- 17 Sep 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years or older and medical clearance to engage in physical exercise
- Those who demonstrated the capacity to comprehend and carry out instructions in a contextualized way through basic directives;
- Those who were independent, as indicated by a score of at least 43 points on the Chilean Ministry of Health's Preventive Medicine Exam for the Older People
- Those who were able to meet the intervention's attendance requirement of at least 85%.
Who cannot join
- Diagnosed with debilitating neurological disorders (e.g., Alzheimer's disease or Parkinson's disease)
- Older people with contraindications to physical exercise, and those with cardiac arrhythmias.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Multicomponent Training Combined With Multi-professional Intervention on Health Status in Hypertensive and Normotensive Older Women
Objective: The objective of this study was to analyze the effects of multicomponent training (MCT) combined with multidisciplinary intervention (nutritional and psychoeducation) on body composition, biochemical markers, and physical performance in hypertensive and normotensive older women. Methods: This longitudinal study included 40 hypertensive and normotensive older women. These older women performed MCT for 36 weeks, during which parameters associated with health status were evaluated (body composition: body fat, fat-free mass; cardiovascular variables: systolic blood pressure (SPBP), diastolic blood pressure (DBP); biochemical markers: glucose, LDL-cholesterol, HDL-cholesterol, total cholesterol, triglycerides; physical performance: arm curl, maximal isometric handgrip strength (MIHS), 30-second chair stand, 6-meter walking test (6MWT), and Timed Up and Go (TUG)). at four time points: baseline (T0), 12 weeks (T1), 24 weeks (T2), and 36 weeks (T3). A two-way mixed analysis of variance with repeated measures was performed.
- Conditions
- Older People
- Being tested
- multicomponent training combined with multi-professional intervention
- Keywords
- Biomarkers, Cardiovascular System, Body Composition, Physical Functional Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent training combined with multi-professional interventionOther
The MCT protocol consisted of an initial three-week period of neuromotor adaptation characterized by low volume and intensity. In the subsequent weeks, a gradual progression of volume and intensity was implemented (Table 1), following a classic linear periodization model (Fleck \& Kraemer, 2017; Prestes et al., 2016).
| Study group | Role | What they receive |
|---|---|---|
| multicomponent training combined | Experimental | The intervention activities consisted of two weekly MCT sessions and one session divided into nutritional and psychological education. The MCT intervention sessions lasted approximately 60 minutes and were conducted on the university premises. The exercises were designed to improve flexibility, strength, mobility, motor coordination, balance, and cardiorespiratory fitness. It should be noted that the MCT program was implemented alternately in indoor and outdoor settings, i.e., one day of the week was devoted to indoor training (gym setting), while another day was devoted to outdoor training (open space). Receives: Other: multicomponent training combined with multi-professional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers analyses
The blood collection procedures followed the guidelines of the Clinical Laboratory Standards Institute . The participants were previously instructed to prepare accordingly for the collections which were conducted at the Clinical Analysis Laboratory of the Institution's facilities. After the blood was drawn, they were advised to apply pressure to the puncture site to prevent bruising. The blood samples were distributed into the following tubes: Vacuplast® collection tubes, tubes containing the anticoagulant ethylenediaminetetraacetic acid (EDTA) K2, and tubes with fluoride/EDTA anticoagulant.
Measured: 36 weeks
Anthropometry
The standing height of the participants was measured via a stadiometer (Welmy R - 110®, Santa Bárbara D'Oeste, São Paulo, Brazil) attached to a scale with a maximum capacity of 2.2 meters and an accuracy of 0.1 cm.
Measured: 36 weeks
Physical performance TUG
Following earlier suggestions, the TUG test was conducted. The person must get out of an arm-supported chair, cross a three-meter aisle, turn around, and return to the chair. They must perform three trials and record the best one in seconds. A pair of evaluators measured the time using single-beam photocells (Brower Timing System, Draper, UT, USA), and the best of three trials was utilized for statistical analysis
Measured: 36 weeks
30-second chair stand
Three repetitions were evaluated to retrieve the best performance executed on the 30-chair stand test. Its purpose was to evaluate the lower limbs' muscle strength, and it is executed while seated in a chair, with the arms resting across the chest, for 30 s.
Measured: 36 weeks
Arm curl Test
In the arm-curl test, participants sat on a chair and were asked to flex the elbow of their stronger arm as many times as possible in 30 seconds while holding a 1-kg dumbbell. Participants were instructed to maintain a normal breathing pattern and keep their elbow at their side during the entire test. A single repetition consisted of full elbow flexion from maximal extension
Measured: 36 weeks
MIHS
Previous studies have recommended the use of MIHS testing. The most suitable testing position was determined to be seated, with the forearm and wrist maintained in a neutral position, the elbow flexed at 90◦ and kept close to the torso, the spine properly aligned, and the shoulder relaxed in a neutral position. A handheld dynamometer (Jamar®, PLUS+, Sammons Preston, Patterson Medical, Warrenville, IL, USA) was used to perform the measurements. To accommodate varying hand sizes and ensure effective engagement of the metacarpophalangeal and interphalangeal joints, the dynamometer was set to the first position, allowing contact between the thumb and the proximal phalanx of the index finger. Participants were given a 120 s rest period between each of the three repetitions per hand.
Measured: 36 weeks
6MWT
Heart rate (HR) was recorded at rest and at the end of each minute during the 6MWT using a lightweight telemetric HR monitor. Oxygen saturation (SpO2) was recorded before and after completing the 6MWT using an oximeter and a finger sensor. At the end of the test, distance was measured and, where appropriate, leg fatigue was assessed using a modified Borg scale from 0 to 10.
Measured: 36 weeks
body composition
Body composition was assessed via a tetrapolar bioelectrical impedance analyzer (InBody 570®, Bio space Co. Ltd., Seoul, South Korea), with a capacity of 250 kg and an accuracy of 100 g, following the manufacturer's instructions and establishing recommendations to increase precision and reliability. The following variables were assessed: body weight (kg), BFP, FFM (kg), and body mass index (BMI, kg/m²).
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start17 Sep 2025
- Primary completion30 Oct 2025
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies 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
- Model description
- The design of this study is descriptive, longitudinal and quasi-experimental in four time points (T0: baseline, T1: 12 weeks, T2: 24 weeks, and T3: 36 weeks) with a frequency of three sessions per week (Monday, Wednesday, and Friday) lasting 60 minutes, which consisted of interventions through MCT, nutritional education, and psychoeducation. The present study was publicized through various communication channels (e.g., television, radio, social media) to recruit participants. Body composition (BFP and FFM), blood pressure (SBP and DBP), biochemical variables (glucose, cholesterol, triglycerides), and physical performance (MIHS, arm curl, 30-second chair stand, 6MWT, and TUG) were evaluated. All measurements were taken in the morning, between 9:00 and 11:00 a.m., and in the same place: Interdisciplinary Laboratory for Health Promotion Interventions (LIIPS) at Cesumar University, Maringa, Paraná Brazil.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Collaborators
- University of Talca, Universidad de Los Lagos
- Responsible party
- Principal investigator, Pablo Valdés-Badilla, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152158
- Sponsor's protocol ID
- 3.373.307
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: They will not be shared, since the data will be private only for the researchers, after prior agreement with the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multicomponent Training Combined With Multi-professional Intervention on Health Status in Hypertensive and Normotensive Older Women
- ClinicalTrials.gov ID
- NCT07152158
- Acronym / sponsor ID
- 3.373.307
- Conditions
- Older People
- Keywords
- Biomarkers, Cardiovascular System, Body Composition, Physical Functional Performance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Collaborators
- University of Talca, Universidad de Los Lagos
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 3 Sep 2025 (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.
Objective: The objective of this study was to analyze the effects of multicomponent training (MCT) combined with multidisciplinary intervention (nutritional and psychoeducation) on body composition, biochemical markers, and physical performance in hypertensive and normotensive older women. Methods: This longitudinal study included 40 hypertensive and normotensive older women. These older women performed MCT for 36 weeks, during which parameters associated with health status were evaluated (body composition: body fat, fat-free mass; cardiovascular variables: systolic blood pressure (SPBP), diastolic blood pressure (DBP); biochemical markers: glucose, LDL-cholesterol, HDL-cholesterol, total cholesterol, triglycerides; physical performance: arm curl, maximal isometric handgrip strength (MIHS), 30-second chair stand, 6-meter walking test (6MWT), and Timed Up and Go (TUG)). at four time points: baseline (T0), 12 weeks (T1), 24 weeks (T2), and 36 weeks (T3). A two-way mixed analysis of variance with repeated measures was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design of this study is descriptive, longitudinal and quasi-experimental in four time points (T0: baseline, T1: 12 weeks, T2: 24 weeks, and T3: 36 weeks) with a frequency of three sessions per week (Monday, Wednesday, and Friday) lasting 60 minutes, which consisted of interventions through MCT, nutritional education, and psychoeducation. The present study was publicized through various communication channels (e.g., television, radio, social media) to recruit participants. Body composition (BFP and FFM), blood pressure (SBP and DBP), biochemical variables (glucose, cholesterol, triglycerides), and physical performance (MIHS, arm curl, 30-second chair stand, 6MWT, and TUG) were evaluated. All measurements were taken in the morning, between 9:00 and 11:00 a.m., and in the same place: Interdisciplinary Laboratory for Health Promotion Interventions (LIIPS) at Cesumar University, Maringa, Paraná Brazil.
| Arm | Type | Receives |
|---|---|---|
| multicomponent training combined | Experimental | Other: multicomponent training combined with multi-professional interventionThe intervention activities consisted of two weekly MCT sessions and one session divided into nutritional and psychological education. The MCT intervention sessions lasted approximately 60 minutes and were conducted on the university premises. The exercises were designed to improve flexibility, strength, mobility, motor coordination, balance, and cardiorespiratory fitness. It should be noted that the MCT program was implemented alternately in indoor and outdoor settings, i.e., one day of the week was devoted to indoor training (gym setting), while another day was devoted to outdoor training (open space). |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 years or older and medical clearance to engage in physical exercise
- Those who demonstrated the capacity to comprehend and carry out instructions in a contextualized way through basic directives;
- Those who were independent, as indicated by a score of at least 43 points on the Chilean Ministry of Health's Preventive Medicine Exam for the Older People
- Those who were able to meet the intervention's attendance requirement of at least 85%.
Key exclusion criteria (2 listed)
- Diagnosed with debilitating neurological disorders (e.g., Alzheimer's disease or Parkinson's disease)
- Older people with contraindications to physical exercise, and those with cardiac arrhythmias.
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 training combined with multi-professional interventionThe MCT protocol consisted of an initial three-week period of neuromotor adaptation characterized by low volume and intensity. In the subsequent weeks, a gradual progression of volume and intensity was implemented (Table 1), following a classic linear periodization model (Fleck \& Kraemer, 2017; Prestes et al., 2016). | Other | multicomponent training combined |
Primary outcome
Biomarkers analyses
Time frame: 36 weeks
The blood collection procedures followed the guidelines of the Clinical Laboratory Standards Institute . The participants were previously instructed to prepare accordingly for the collections which were conducted at the Clinical Analysis Laboratory of the Institution's facilities. After the blood was drawn, they were advised to apply pressure to the puncture site to prevent bruising. The blood samples were distributed into the following tubes: Vacuplast® collection tubes, tubes containing the anticoagulant ethylenediaminetetraacetic acid (EDTA) K2, and tubes with fluoride/EDTA anticoagulant.
Anthropometry
Time frame: 36 weeks
The standing height of the participants was measured via a stadiometer (Welmy R - 110®, Santa Bárbara D'Oeste, São Paulo, Brazil) attached to a scale with a maximum capacity of 2.2 meters and an accuracy of 0.1 cm.
Physical performance TUG
Time frame: 36 weeks
Following earlier suggestions, the TUG test was conducted. The person must get out of an arm-supported chair, cross a three-meter aisle, turn around, and return to the chair. They must perform three trials and record the best one in seconds. A pair of evaluators measured the time using single-beam photocells (Brower Timing System, Draper, UT, USA), and the best of three trials was utilized for statistical analysis
30-second chair stand
Time frame: 36 weeks
Three repetitions were evaluated to retrieve the best performance executed on the 30-chair stand test. Its purpose was to evaluate the lower limbs' muscle strength, and it is executed while seated in a chair, with the arms resting across the chest, for 30 s.
Arm curl Test
Time frame: 36 weeks
In the arm-curl test, participants sat on a chair and were asked to flex the elbow of their stronger arm as many times as possible in 30 seconds while holding a 1-kg dumbbell. Participants were instructed to maintain a normal breathing pattern and keep their elbow at their side during the entire test. A single repetition consisted of full elbow flexion from maximal extension
MIHS
Time frame: 36 weeks
Previous studies have recommended the use of MIHS testing. The most suitable testing position was determined to be seated, with the forearm and wrist maintained in a neutral position, the elbow flexed at 90◦ and kept close to the torso, the spine properly aligned, and the shoulder relaxed in a neutral position. A handheld dynamometer (Jamar®, PLUS+, Sammons Preston, Patterson Medical, Warrenville, IL, USA) was used to perform the measurements. To accommodate varying hand sizes and ensure effective engagement of the metacarpophalangeal and interphalangeal joints, the dynamometer was set to the first position, allowing contact between the thumb and the proximal phalanx of the index finger. Participants were given a 120 s rest period between each of the three repetitions per hand.
6MWT
Time frame: 36 weeks
Heart rate (HR) was recorded at rest and at the end of each minute during the 6MWT using a lightweight telemetric HR monitor. Oxygen saturation (SpO2) was recorded before and after completing the 6MWT using an oximeter and a finger sensor. At the end of the test, distance was measured and, where appropriate, leg fatigue was assessed using a modified Borg scale from 0 to 10.
body composition
Time frame: 36 weeks
Body composition was assessed via a tetrapolar bioelectrical impedance analyzer (InBody 570®, Bio space Co. Ltd., Seoul, South Korea), with a capacity of 250 kg and an accuracy of 100 g, following the manufacturer's instructions and establishing recommendations to increase precision and reliability. The following variables were assessed: body weight (kg), BFP, FFM (kg), and body mass index (BMI, kg/m²).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No. They will not be shared, since the data will be private only for the researchers, after prior agreement with the ethics committee.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 combined with multi-professional intervention in people with Older People, run by Universidad Católica del Maule at 1 site in Chile.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
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?
Biomarkers analyses (time frame: 36 weeks). The study lists 8 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 2 Jan 2026.