ObeseNCT05061173
Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
A study testing Aerobic exercise training Group, Resistance Exercise Training Group and Combined Exercise Training Group in people with Obese and Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of aerobic, resistance and combined training in hypertensive obese patients Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Obese, Hypertension
- What is being tested?
- Aerobic exercise training Group, Resistance Exercise Training Group and Combined Exercise Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2021to 30 Aug 2022
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive with BP greater than 140/90 mmHg
- Overweight and obese adults with BMI (25-40)
- Physically inactive from past 6 months assessed with pedometer. Those with step count of less than 7000 will be included
- To be able to exercise (6MWT),t hose who completed the test without any symptom
Who cannot join
- Any active systemic illness that restricts exercise
- People doing exercise on regular basis
- Any cardiopulmonary , metabolic and neurological illness
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
District Headquarter Hospital - kotli
Kotli, Azad Jamu Kashmir, 11100
About this study
Official title: Compare the Effects of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
To compare the effects of aerobic, resistance and combined training in hypertensive obese patients
- Conditions
- Obese, Hypertension
- Being tested
- Aerobic exercise training Group, Resistance Exercise Training Group, Combined Exercise Training Group
- Keywords
- Aerobic Exercise, Resistive exercise, Combined Aerobic and Resistive Exercise
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise training GroupOther
Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 30 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 30 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 30 minutes
Resistance Exercise Training GroupOther
Resistive Exercises includes (a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction.
At Week 1-2, 10 repetitions 1 set, 3 days/week, for 30 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 30 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 30 minutes
Combined Exercise Training GroupOther
Combined Exercise training includes [Aerobic: Treadmill walking + Resistive Training: a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction] Time will be reduced to 15 minutes for both trainings in respective weeks. Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 15 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 15 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 15 minutes
Resistive Exercises At Week 1-2, 10 repetitions 1 set, 3 days/week, for 15 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 15 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise training Group | Experimental | Not described Receives: Other: Aerobic exercise training Group |
| Resistance Exercise Training Group | Experimental | Not described Receives: Other: Resistance Exercise Training Group |
| Combined Exercise Training Group | Experimental | Not described Receives: Other: Combined Exercise Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Measured: 6 weeks
Body Mass Index (BMI)
Changes from the Baseline, Body mass index (BMI) will be calculated as weight (kg)/height (m2). Below 18.5 Underweight 18.5 - 24.9 Healthy Weight 25.0 - 29.9 Overweight 30.0 and Above Obesity
Measured: 6 Week
Change in blood lipid profile
Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.
Measured: 6 Week
Step Count
Pedometer is a valid self-report measure of physical activity. Pedometer is used to count the average daily steps. Change from the baseline to 6 week will be compared.
Measured: 6 week
Waist circumference
Waist circumference will be measured for abdominal or central fat mass. It is measured in cm at the middle distance between the last floating rib and the iliac crest using a retractable ergonomic measuring tape. Change from the baseline to 6 week will be compared.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start10 Sep 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061173
- Sponsor's protocol ID
- REC/01083 Sidra Asghar
- Status last verified
- Oct 2022
- First submitted
- 18 Sep 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effects of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
- ClinicalTrials.gov ID
- NCT05061173
- Acronym / sponsor ID
- REC/01083 Sidra Asghar
- Conditions
- Obese, Hypertension
- Keywords
- Aerobic Exercise, Resistive exercise, Combined Aerobic and Resistive Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 29 Sep 2021 (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.
To compare the effects of aerobic, resistance and combined training in hypertensive obese patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training Group | Experimental | Other: Aerobic exercise training Group |
| Resistance Exercise Training Group | Experimental | Other: Resistance Exercise Training Group |
| Combined Exercise Training Group | Experimental | Other: Combined Exercise Training Group |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertensive with BP greater than 140/90 mmHg
- Overweight and obese adults with BMI (25-40)
- Physically inactive from past 6 months assessed with pedometer. Those with step count of less than 7000 will be included
- To be able to exercise (6MWT),t hose who completed the test without any symptom
Key exclusion criteria (3 listed)
- Any active systemic illness that restricts exercise
- People doing exercise on regular basis
- Any cardiopulmonary , metabolic and neurological illness
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 |
|---|---|---|
| Aerobic exercise training GroupAerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 30 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 30 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 30 minutes | Other | Aerobic exercise training Group |
| Resistance Exercise Training GroupResistive Exercises includes (a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction. At Week 1-2, 10 repetitions 1 set, 3 days/week, for 30 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 30 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 30 minutes | Other | Resistance Exercise Training Group |
| Combined Exercise Training GroupCombined Exercise training includes [Aerobic: Treadmill walking + Resistive Training: a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction] Time will be reduced to 15 minutes for both trainings in respective weeks. Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 15 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 15 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 15 minutes Resistive Exercises At Week 1-2, 10 repetitions 1 set, 3 days/week, for 15 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 15 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 15 minutes | Other | Combined Exercise Training Group |
Primary outcome
Systolic and diastolic blood pressure
Time frame: 6 weeks
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Body Mass Index (BMI)
Time frame: 6 Week
Changes from the Baseline, Body mass index (BMI) will be calculated as weight (kg)/height (m2). Below 18.5 Underweight 18.5 - 24.9 Healthy Weight 25.0 - 29.9 Overweight 30.0 and Above Obesity
Change in blood lipid profile
Time frame: 6 Week
Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.
Step Count
Time frame: 6 week
Pedometer is a valid self-report measure of physical activity. Pedometer is used to count the average daily steps. Change from the baseline to 6 week will be compared.
Waist circumference
Time frame: 6 week
Waist circumference will be measured for abdominal or central fat mass. It is measured in cm at the middle distance between the last floating rib and the iliac crest using a retractable ergonomic measuring tape. Change from the baseline to 6 week will be compared.
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 24 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Muhammad Iqbal Tariq, MSCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training Group, Resistance Exercise Training Group and Combined Exercise Training Group in people with Obese and Hypertension, run by Riphah International University at 1 site in Pakistan.
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 3 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 24 Oct 2022. 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 Pakistan. 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?
Systolic and diastolic blood pressure (time frame: 6 weeks). The study lists 5 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 24 Oct 2022.