An interventional study of Multicomponent exercise program in Hypertension and Cardiovascular Risk, sponsored by Universidad Pedagogica Nacional, Colombia. Completed at 1 site in Colombia. Open to female participants aged 45 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Universidad Pedagogica Nacional, Colombia · Not applicable, Interventional, and Treatment
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 32 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Universidad Pedagogica Nacional, Colombia is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Multicomponent exercise program
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.
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).
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.
Time frame: 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.
Time frame: Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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.
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
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.
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
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.
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
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.
Time frame: Baseline (June 2026) and week 12 of the program (completed between 17 and 19 September 2026)
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Pedagogica Nacional, Colombia