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IRCT20220615055181N1 IRCT 2023-02-15 Self funded Effect of exercises on hypertension Effectiveness of Aerobic, Resistance, and Combined Training on Hypertension Patients: A randomized Controlled Trial 2021-12-01 anticipated 48 Complete https://irct.ir/trial/68491 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects were 48 adults with T2DM who were attending the diabetes clinic of the Finoteselam referral hospital were randomly assigned to one of four groups using a random numbered table: the aerobic intervention group (aerobic IG), the strength intervention group (strength IG), the combined both aerobic and strength intervention group (combined IG) or control group (CG). We used a simple randomization method for individual patients. Mechanism used to implement the random allocation sequence was a random numbered table by staffs who were not assessors of the outcome, Blinding description: The participants were assigned randomly to three intervention groups and a control group. In our study the following groups are involved blindly: fitness professionals who provide exercise interventions, data collectors, outcome assessors, lab technicians and investigator-initiated trials. N/A Comparing the effects of aerobic, resistance, and a combination of aerobic plus resistance training on blood pressure (BP), cardiorespiratory fitness (CRF) and body composition.. Intervention 1: Intervention group: aerobic exercise intervention: During the 12-week training period, all study participants, with the exception of the non-exercise control group, exercised for 60 minutes, which included 5 minutes of warming up and 5 minutes of cooling down. All training sessions were overseen by health fitness professionals and exercise physiologists. The exercise regimens developed by the American College of Sports Medicine (Garber, Blissmer, Deschenes, Franklin, Lamonte, Lee, Nieman, & Swain, 2011; Pescatello, Franclin, Fagard, & Faqquhar, 2004) served as the foundation. The aerobic exercise-only group performed floor aerobics or aerobic dance at an initial heart rate of 40% and gradually increased to approximately 70% as the intervention progressed. The heart rate monitor that was worn by the participants throughout each exercise session recorded their maximum heart rate, which could be exercised at an intensity that did not exceed 80% of their maximum heart rate. Intervention 2: Intervention group: strength exercise intervention group: The only resistance group that includes standing plantar flexion, triceps pulley, neutral rowing, squatting, dumbbell supine, knee extension with ankle weights, dumbbell development, dumbbell curl and trunk flexion and vertical bench press (Carvalho et al., 2019). The circuit type of resistance training (RT) was used with intervals of 15–20 s between exercises, with 3 sets of 10 repetitions with a rest of 1–2 minutes between sets. Due to the patients' lack of physical fitness and motor coordination, the loads were determined by their perceived exertion using the scale of 6 to 20 proposed by Borg in 1982 (Borg, 1982). The values used were 11 to 13, which represented a moderate effort. The load was then increased with the goal of maintaining constant value of perceived exertion. Intervention 3: Intervention group: Combined aerobic plus strength intervention group. The combined group participated in 30 minutes of resistance training and 30 minutes of aerobic exercise at the same intensity, progression, and method in each session. The only difference for aerobic exercise was that it was cut down to 30 minutes rather than 60. With the exception of the neutral rowing, dumbbell supine, dumbbell development and standing plantar flexion, these participants performed their resistance training with the same intensity and protocol as the afore-mentioned individual groups, reducing it to six exercises instead of ten and two sets instead of three. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data (IPD) collected in this study will be available to other researchers (typically after publication of this study). The measured data on blood pressure (BP), cardiorespiratory fitness (CRF) and body composition will be share to other researchers. The data sharing plan of this trial includes study protocol, statistical analysis plan, informed consent form and summary reports of the trial. When: The data files will become available when summary data are published. To whom: Scholars: this is only available for people working in academic institutions. Conditions: Accessing criteria for this deidentified IPD and any additional supporting information/documents will be for research purpose, to design strategies for prevention and management of blood pressure, weight management and cardiovascular diseases. Scholars can request who are from academic institutions (students, teachers and researchers). Where to obtain: This trial data is available from corresponding author (Getu Teferi). How to obtain: To scholars from academic institution can access the data from corresponding author through email (teferigetu36@gmail.com). Comments:
public Getu Teferi
Kebel 08, Debremarkos
Debremarkos Ethiopia 269 +251 93 620 6383 teferigetu36@gmail.com Debremarkos University scientific Getu Teferi
Kebel 08, Debremarkos
Debremarkos Ethiopia 269 +251 93 620 6383 teferigetu36@gmail.com Debremarkos University Ethiopia Criteria for inclusion: 1) All consenting patients with hypertension between the ages of 18 and 65. 2) Individuals with hypertension who have been treated for at least three months. 3) Stage 1 and 2 hypertension patients who are willing to participate in the study (systolic blood pressure < 180 mmHg and diastolic blood pressure < 100 mmHg) (41), 4) reside in the town of Finoteselam, 5) do not have any injuries. 6) For at least the last three months, patients were sedentary. 35 years no limit Male Criteria for rejection:1) People who are unfit for exercise and have hypertension-related complications, such as coronary heart disease, congestive heart failure, and cerebrovascular disease. 2) people who have other co-morbidities, such as diabetes mellitus, chronic kidney disease, and musculoskeletal injuries, that prevent them from exercising. Our study focuses on the effect of different exercise modalities on blood pressure (BP), cardiorespiratory fitness (CRF) and body composition. That means we were studying on the effect of exercise on hypertension patients. Other Other Other Intervention group: aerobic exercise intervention: During the 12-week training period, all study participants, with the exception of the non-exercise control group, exercised for 60 minutes, which included 5 minutes of warming up and 5 minutes of cooling down. All training sessions were overseen by health fitness professionals and exercise physiologists. The exercise regimens developed by the American College of Sports Medicine (Garber, Blissmer, Deschenes, Franklin, Lamonte, Lee, Nieman, & Swain, 2011; Pescatello, Franclin, Fagard, & Faqquhar, 2004) served as the foundation. The aerobic exercise-only group performed floor aerobics or aerobic dance at an initial heart rate of 40% and gradually increased to approximately 70% as the intervention progressed. The heart rate monitor that was worn by the participants throughout each exercise session recorded their maximum heart rate, which could be exercised at an intensity that did not exceed 80% of their maximum heart rate. Intervention group: strength exercise intervention group: The only resistance group that includes standing plantar flexion, triceps pulley, neutral rowing, squatting, dumbbell supine, knee extension with ankle weights, dumbbell development, dumbbell curl and trunk flexion and vertical bench press (Carvalho et al., 2019). The circuit type of resistance training (RT) was used with intervals of 15–20 s between exercises, with 3 sets of 10 repetitions with a rest of 1–2 minutes between sets. Due to the patients' lack of physical fitness and motor coordination, the loads were determined by their perceived exertion using the scale of 6 to 20 proposed by Borg in 1982 (Borg, 1982). The values used were 11 to 13, which represented a moderate effort. The load was then increased with the goal of maintaining constant value of perceived exertion. Intervention group: Combined aerobic plus strength intervention group. The combined group participated in 30 minutes of resistance training and 30 minutes of aerobic exercise at the same intensity, progression, and method in each session. The only difference for aerobic exercise was that it was cut down to 30 minutes rather than 60. With the exception of the neutral rowing, dumbbell supine, dumbbell development and standing plantar flexion, these participants performed their resistance training with the same intensity and protocol as the afore-mentioned individual groups, reducing it to six exercises instead of ten and two sets instead of three. The primary outcome variable of this trial is blood pressure (systolic and diastolic blood pressure). Timepoint: The baseline (pre-test) data were gathered; at week 1, prior to the intervention (also known as the baseline or pre-intervention), and at week 13, after the 12-week intervention (also known as the post-intervention). Method of measurement: The automated Sphygmacor XCEL (AtCor Medical, Itasca, IL, USA) was used to measure blood pressure and resting heart rate. The participant was seated with their legs straight and a brachial pressure cuff placed over the brachial artery on their left arm. The device measured the brachial systolic and diastolic blood pressure three times, with a two-minute rest in between each measurement. For all measurements, the SphygmaCor XCEL reported the average of the last two readings instead of the initial reading. The second outcome variable of this trial is body composition (body fat percentage and body mass index). Timepoint: The baseline (pre-test) data were gathered; at week 1, prior to the intervention (also known as the baseline or pre-intervention), and at week 13, after the 12-week intervention (also known as the post-intervention). Method of measurement: The body mass index was calculated by dividing the height in meters squared by the body weight in kilograms using a standard stadiometer. The body fat percentage was measured using a skinfold caliper. With the help of a skinfold caliper and a properly trained technician, the skinfold percentage of body fat can be determined with great precision. Gender and age are thought to have an impact on the ratio of subcutaneous fat to total fat (Medicine, 2013). Based on the specific recommendations of (Medicine, 2013), we used the Jackson-Pollock 3-Site Skinfold Formula for Body Density J-P 3-Site (Jackson & Pollock, 1985) for this study. As a result, the three site: triceps, suprailiac, and abdominal sites were used to measure women's body fat using the three-site formula: Body Density = 1.089733 - 0.0009245 (sum of three skinfolds) + 0.0000025 (sum of three skinfolds)2 - 0.0000979 (age), whereas for men, the three-site formula for the chest, triceps, and subscapular is as follows: Body Density is equal to 1.1125025 minus 0.0013125 (sum of three skinfolds) plus 0.0000055 (sum of three skinfolds)2 minus 0.000244. Body Density (BD) can be used to determine the percentage of body fat, according to the Siri Equation(Jackson & Pollock, 1985) :The percentage of body fat calculated using the Siri Equation is: % BF = 495/BD – 450. The third outcome variable of this trial is cardiorespiratory fitness. Timepoint: The baseline (pre-test) data were gathered; at week 1, prior to the intervention (also known as the baseline or pre-intervention), and at week 13, after the 12-week intervention (also known as the post-intervention). Method of measurement: Queens College Step Test was employed to measure cardiovascular endurance. The subjects will be started by steps up and down on the platform at a given rate for three minutes. For three minutes, the subjects would begin by moving up and down on the platform at a predetermined rate. This action will be repeated, and the test will continue until the allotted amount of time has passed. Stepping time and/or heart rate after exercise are used to calculate the results. After completing the test, participants use their index finger to locate the radial or carotid arteries. Subjects will be counted for the number of heartbeats (pulses) that occur over a 15-second period following the discovery of radial or carotid pulse. By multiplying the number of heartbeats counted in 15 seconds by 4, heart rates for one minute can be calculated. The recovery HR is then used to calculate the subject's Vo2max in mL'kg-I'min-1 using the following formula: Men:Vo2max = mL kg-1min-1) = 111.33 - (0.42.HR) (Davis, 2008). Self funded Approved 2021-12-08 Research ethics committee Kebel 08, Debremarkos Debremarkos Ethiopia Ethiopia