Multicomponent Exercise Program in Women With Hypertension
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Bogota D.C.
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Bogotá、Bogota D.C.、コロンビア
- Community spaces, Restrepo neighborhood (Antonio Nariño locality)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Multicomponent exercise program
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. |
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). |
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介入なし：Control
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in resting systolic blood pressure (SBP) from baseline to week 12
時間枠：Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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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. |
Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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Change in resting diastolic blood pressure (DBP) from baseline to week 12
時間枠：Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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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. |
Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in estimated cardiorespiratory fitness (estimated VO2) from baseline to week 12
時間枠：Baseline (24 and 26 June 2026) and week 12 of the program (19 September 2026)
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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. |
Baseline (24 and 26 June 2026) and week 12 of the program (19 September 2026)
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Change in handgrip strength, dominant hand, from baseline to week 12
時間枠：Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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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. |
Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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Change in handgrip strength, non-dominant hand, from baseline to week 12
時間枠：Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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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. |
Baseline (24 and 26 June 2026) and week 12 of the program (17 September 2026)
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Change in health-related quality of life (SF-36 domain scores) from baseline to week 12
時間枠：Baseline (June 2026) and week 12 of the program (completed between 17 and 19 September 2026)
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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. |
Baseline (June 2026) and week 12 of the program (completed between 17 and 19 September 2026)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 340ETIC-041-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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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