HypertensionNCT07913971
Multicomponent Exercise Program in Women With Hypertension
A study testing Multicomponent exercise program in people with Hypertension and Cardiovascular Risk, run by Universidad Pedagogica Nacional, Colombia at 1 site in Colombia.
Trial summary
This study tested whether a 12-week supervised multicomponent exercise program is associated with changes in blood pressure, estimated cardiorespiratory fitness, handgrip strength and health-related quality of life in women aged 45 to 59 years with hypertension. Read more about this study
- Who is it for?
- Ages 45 to 59 years, women only
- Conditions the study is for
- Hypertension, Cardiovascular Risk
- What is being tested?
- Multicomponent exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteColombia
- Study dates
- 24 Jun 2026to 19 Sep 2026
- 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 45 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 45 to 59 years
- Medically confirmed diagnosis of essential arterial hypertension
- Medical clearance to practice exercise
- Low physical activity level or sedentary
- Ability to sign informed consent
- Availability to comply with the intervention program
- Stable clinical condition
- No use of substances that alter the physiological response
Who cannot join
- Men or outside the age range
- Secondary or unconfirmed hypertension
- Medical contraindication to exercise
- Recent participation in structured exercise programs
- Cognitive difficulty or refusal to participate
- Low adherence or inability to attend
- Recent cardiovascular events
- Use of substances that interfere with the study
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Community spaces, Restrepo neighborhood (Antonio Nariño locality)
Bogotá, Bogota D.C.
About this study
Official title: Effects of a Multicomponent Physical Exercise Program on Blood Pressure Parameters, Cardiorespiratory Capacity, Handgrip Strength and Quality of Life in Hypertensive Women With Cardiovascular Risk
This study tested whether a 12-week supervised multicomponent exercise program is associated with changes in blood pressure, estimated cardiorespiratory fitness, handgrip strength and health-related quality of life in women aged 45 to 59 years with hypertension. The program combined strength training, aerobic exercise (brisk walking or light jogging), controlled breathing and flexibility, in three sessions per week of about 60 minutes, mainly in community spaces in Bogotá, Colombia, with a hybrid option for women who could not attend in person. Thirty-two women were assigned, by convenience according to their availability for the class schedule, to an exercise group (n = 16) or to a control group that kept its usual activities (n = 16). Systolic and diastolic blood pressure, estimated cardiorespiratory fitness (Rockport 1-mile walk test), handgrip strength (dynamometer) and quality of life (SF-36 questionnaire) were measured before and after the 12 weeks.
Read the detailed description
Design: non-randomized, parallel-group, quasi-experimental study with pre- and post-intervention measurements in an exercise group and a control group.
Recruitment and setting: participants were recruited in Bogotá, Colombia, during the two months before the baseline assessment (approximately from late April 2026), through an information session and written informed consent. The program was delivered mainly in community spaces in the Restrepo neighborhood (Antonio Nariño locality), with a hybrid option for participants who could not attend in person.
Timeline: baseline assessments were carried out on 24 and 26 June 2026 and the program started on 30 June 2026. Post-intervention assessments were carried out in week 12: blood pressure, handgrip strength and anthropometry on 17 September 2026 (about 48 hours after the last session), the Rockport walk test on 19 September 2026, and the SF-36 questionnaire was completed by participants between 17 and 19 September 2026.
Program: the exercise program followed the FITT-VP model (frequency, intensity, time, type, volume and progression), with progression in three phases (anatomical conditioning, development and consolidation). Exercise intensity was monitored with the OMNI perceived exertion scale (0-10), and heart rate was checked with a chest strap in a random subset of participants. In week 6, the exercise group completed tolerance check tests (blood pressure, cardiorespiratory fitness and handgrip strength) only to decide whether the plan needed adjustments; these were not part of the confirmatory analysis. The control group maintained its usual activities.
Analysis: the main analysis was a 2 x 2 mixed ANOVA (Group x Time), with the Group x Time interaction as the key parameter. An ANCOVA on post-intervention diastolic blood pressure, with baseline diastolic blood pressure as covariate, was added after a baseline imbalance was detected and was not specified in the original protocol.
REGISTRATION NOTE: this study was registered retrospectively, after data collection had been completed.
- Conditions
- Hypertension, Cardiovascular Risk
- Being tested
- Multicomponent exercise program
- Keywords
- Exercise, Multicomponent exercise, Blood pressure, Cardiorespiratory fitness, Handgrip strength, Quality of life, Middle-aged women, Quasi-experimental study
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise programBehavioural
Supervised program of 12 weeks, three sessions per week (up to 60 minutes). Components: muscular strength training with elastic bands and body weight (squat, step-up, incline push-up, band row, farmer walk); aerobic exercise (brisk walking or jogging, rhythmic cardio-boxing and interval work at a prescribed intensity); controlled breathing (square breathing 4x4x4x4, diaphragmatic, pursed-lip and slow breathing) and flexibility (pectoral, hamstring, iliopsoas and lateral trunk stretches). Load progressed over three phases. Intensity was monitored with the OMNI perceived exertion scale (0-10) and, in a random subset of participants, with a chest-strap heart rate monitor (Polar H10).
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise program | Experimental | Supervised multicomponent exercise program for 12 weeks, three sessions per week (up to 60 minutes), combining strength training, aerobic exercise (brisk walking, rhythmic cardio-boxing and interval work), controlled breathing and flexibility. Program planned with the FITT-VP model and progressed in three phases (anatomical conditioning, development and consolidation). Delivered mainly in community spaces, with a hybrid option for participants who could not attend in person. Receives: Behavioral: Multicomponent exercise program |
| Control | No intervention | Women with hypertension who maintained their usual activities during the 12 weeks and received no exercise program. They were assessed before and after the same period with the same instruments as the exercise group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting systolic blood pressure (SBP) from baseline to week 12
Resting systolic blood pressure in mmHg, measured with an automated upper-arm monitor (Omron HEM-716DT2). Three measurements at rest (at least 5 minutes of rest); the mean of the second and third measurements is used. Change = post-intervention value minus baseline value. Between-group difference in change tested with the Group x Time interaction of a 2 x 2 mixed ANOVA.
Measured: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
Change in resting diastolic blood pressure (DBP) from baseline to week 12
Resting diastolic blood pressure in mmHg, measured with an automated upper-arm monitor (Omron HEM-716DT2). Three measurements at rest (at least 5 minutes of rest); the mean of the second and third measurements is used. Change = post-intervention value minus baseline value. Tested with the Group x Time interaction of a 2 x 2 mixed ANOVA. An ANCOVA on post-intervention DBP with baseline DBP as covariate was added after a baseline imbalance was detected and was not specified in the original protocol.
Measured: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
Secondary outcomes (4)
Change in estimated cardiorespiratory fitness (estimated VO2) from baseline to week 12
Estimated VO2 in ml/kg/min from the Rockport 1-mile (1,609 m) walk test, using walking time and final heart rate (recorded with a chest strap, Polar H10) in the equation of Kline et al. (1987). This is an estimate and not a direct measurement of maximal oxygen uptake. Change = post-intervention minus baseline.
Measured: Baseline (24 and 26 June 2026) and week 12 of the program (19 September 2026)
Change in handgrip strength, dominant hand, from baseline to week 12
Maximal handgrip strength of the dominant hand in kg, measured with a hand dynamometer (Camry EH101). Three attempts; the maximum value is recorded. Change = post-intervention minus baseline.
Measured: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
Change in handgrip strength, non-dominant hand, from baseline to week 12
Maximal handgrip strength of the non-dominant hand in kg, measured with a hand dynamometer (Camry EH101). Three attempts; the maximum value is recorded. Change = post-intervention minus baseline.
Measured: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
Change in health-related quality of life (SF-36 domain scores) from baseline to week 12
SF-36 questionnaire, scored 0-100 for each of its eight domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health); higher scores indicate better perceived health. Each domain was analyzed separately; no global SF-36 score was calculated. Change = post-intervention minus baseline.
Measured: Baseline (June 2026) and week 12 of the program (completed between 17 and 19 September 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start24 Jun 2026
- Primary completion17 Sep 2026
- Study completion19 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: a multicomponent exercise program group and a control group that maintained usual activities. Participants were assigned by convenience according to their availability for the class schedule (non-randomized).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pedagogica Nacional, Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Fernando Rodríguez Triana, Universidad Pedagogica Nacional, Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913971
- Sponsor's protocol ID
- 340ETIC-041-2026
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent guaranteed participants that only aggregated results would be published and that identifiable data would be accessible only to the research team.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Physical Exercise Program on Blood Pressure Parameters, Cardiorespiratory Capacity, Handgrip Strength and Quality of Life in Hypertensive Women With Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT07913971
- Acronym / sponsor ID
- 340ETIC-041-2026
- Conditions
- Hypertension, Cardiovascular Risk
- Keywords
- Exercise, Multicomponent exercise, Blood pressure, Cardiorespiratory fitness, Handgrip strength, Quality of life, Middle-aged women, Quasi-experimental study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Pedagogica Nacional, ColombiaUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 19 Sep 2026 (actual)
- First posted
- 3 Nov 2026 (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 tested whether a 12-week supervised multicomponent exercise program is associated with changes in blood pressure, estimated cardiorespiratory fitness, handgrip strength and health-related quality of life in women aged 45 to 59 years with hypertension. The program combined strength training, aerobic exercise (brisk walking or light jogging), controlled breathing and flexibility, in three sessions per week of about 60 minutes, mainly in community spaces in Bogotá, Colombia, with a hybrid option for women who could not attend in person. Thirty-two women were assigned, by convenience according to their availability for the class schedule, to an exercise group (n = 16) or to a control group that kept its usual activities (n = 16). Systolic and diastolic blood pressure, estimated cardiorespiratory fitness (Rockport 1-mile walk test), handgrip strength (dynamometer) and quality of life (SF-36 questionnaire) were measured before and after the 12 weeks.
Detailed description
Design: non-randomized, parallel-group, quasi-experimental study with pre- and post-intervention measurements in an exercise group and a control group.
Recruitment and setting: participants were recruited in Bogotá, Colombia, during the two months before the baseline assessment (approximately from late April 2026), through an information session and written informed consent. The program was delivered mainly in community spaces in the Restrepo neighborhood (Antonio Nariño locality), with a hybrid option for participants who could not attend in person.
Timeline: baseline assessments were carried out on 24 and 26 June 2026 and the program started on 30 June 2026. Post-intervention assessments were carried out in week 12: blood pressure, handgrip strength and anthropometry on 17 September 2026 (about 48 hours after the last session), the Rockport walk test on 19 September 2026, and the SF-36 questionnaire was completed by participants between 17 and 19 September 2026.
Program: the exercise program followed the FITT-VP model (frequency, intensity, time, type, volume and progression), with progression in three phases (anatomical conditioning, development and consolidation). Exercise intensity was monitored with the OMNI perceived exertion scale (0-10), and heart rate was checked with a chest strap in a random subset of participants. In week 6, the exercise group completed tolerance check tests (blood pressure, cardiorespiratory fitness and handgrip strength) only to decide whether the plan needed adjustments; these were not part of the confirmatory analysis. The control group maintained its usual activities.
Analysis: the main analysis was a 2 x 2 mixed ANOVA (Group x Time), with the Group x Time interaction as the key parameter. An ANCOVA on post-intervention diastolic blood pressure, with baseline diastolic blood pressure as covariate, was added after a baseline imbalance was detected and was not specified in the original protocol.
REGISTRATION NOTE: this study was registered retrospectively, after data collection had been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups: a multicomponent exercise program group and a control group that maintained usual activities. Participants were assigned by convenience according to their availability for the class schedule (non-randomized).
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise program | Experimental | Behavioral: Multicomponent exercise programSupervised multicomponent exercise program for 12 weeks, three sessions per week (up to 60 minutes), combining strength training, aerobic exercise (brisk walking, rhythmic cardio-boxing and interval work), controlled breathing and flexibility. Program planned with the FITT-VP model and progressed in three phases (anatomical conditioning, development and consolidation). Delivered mainly in community spaces, with a hybrid option for participants who could not attend in person. |
| Control | No intervention | –Women with hypertension who maintained their usual activities during the 12 weeks and received no exercise program. They were assessed before and after the same period with the same instruments as the exercise group. |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women aged 45 to 59 years
- Medically confirmed diagnosis of essential arterial hypertension
- Medical clearance to practice exercise
- Low physical activity level or sedentary
- Ability to sign informed consent
Key exclusion criteria (8 listed)
- Men or outside the age range
- Secondary or unconfirmed hypertension
- Medical contraindication to exercise
- Recent participation in structured exercise programs
- Cognitive difficulty or refusal to participate
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 exercise programSupervised program of 12 weeks, three sessions per week (up to 60 minutes). Components: muscular strength training with elastic bands and body weight (squat, step-up, incline push-up, band row, farmer walk); aerobic exercise (brisk walking or jogging, rhythmic cardio-boxing and interval work at a prescribed intensity); controlled breathing (square breathing 4x4x4x4, diaphragmatic, pursed-lip and slow breathing) and flexibility (pectoral, hamstring, iliopsoas and lateral trunk stretches). Load progressed over three phases. Intensity was monitored with the OMNI perceived exertion scale (0-10) and, in a random subset of participants, with a chest-strap heart rate monitor (Polar H10). | Behavioural | Multicomponent exercise program |
Primary outcome
Change in resting systolic blood pressure (SBP) from baseline to week 12
Time frame: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
Resting systolic blood pressure in mmHg, measured with an automated upper-arm monitor (Omron HEM-716DT2). Three measurements at rest (at least 5 minutes of rest); the mean of the second and third measurements is used. Change = post-intervention value minus baseline value. Between-group difference in change tested with the Group x Time interaction of a 2 x 2 mixed ANOVA.
Change in resting diastolic blood pressure (DBP) from baseline to week 12
Time frame: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
Resting diastolic blood pressure in mmHg, measured with an automated upper-arm monitor (Omron HEM-716DT2). Three measurements at rest (at least 5 minutes of rest); the mean of the second and third measurements is used. Change = post-intervention value minus baseline value. Tested with the Group x Time interaction of a 2 x 2 mixed ANOVA. An ANCOVA on post-intervention DBP with baseline DBP as covariate was added after a baseline imbalance was detected and was not specified in the original protocol.
4 secondary outcomes
Change in estimated cardiorespiratory fitness (estimated VO2) from baseline to week 12
Time frame: Baseline (24 and 26 June 2026) and week 12 of the program (19 September 2026)
Change in handgrip strength, dominant hand, from baseline to week 12
Time frame: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
Change in handgrip strength, non-dominant hand, from baseline to week 12
Time frame: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
Change in health-related quality of life (SF-36 domain scores) from baseline to week 12
Time frame: Baseline (June 2026) and week 12 of the program (completed between 17 and 19 September 2026)
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 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent guaranteed participants that only aggregated results would be published and that identifiable data would be accessible only to the research team.
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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 exercise program in people with Hypertension and Cardiovascular Risk, run by Universidad Pedagogica Nacional, Colombia at 1 site in Colombia.
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 8 inclusion and 8 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 3 Nov 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 Colombia. 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?
Change in resting systolic blood pressure (SBP) from baseline to week 12 (time frame: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)). 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 3 Nov 2026.