Blood PressureNCT05936892
Comparative Effects of UE Aerobic and Resistance Training on Cardiorespiratory Fitness in Hypertensive Patients
A study testing upper extremity aerobic training and upper extremity resistance training in people with Blood Pressure, run by Riphah International University at 1 site in Pakistan.
Trial summary
simple random sampling into group A \& group B to collect data. Group A will be given upper extremity aerobic training and group B will be given upper extremity resistance training. The study will be completed within the time duration of ten months. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- upper extremity aerobic training and upper extremity resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2023to 20 Nov 2023
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group of 35-65years
- Both male and females
- Patients with blood pressure >140/90mm Hg
Who cannot join
- Regular engagement in physical exercise training in past 4 weeks
- Patients with secondary hypertension
- Patients using more than one hypertensive drugs
- Recent myocardial infarction
- Congestive heart failure
- Uncontrolled cardiac arrythmia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Multan Institute of Cardiology, Multan
Multan Khurd, Punjab Province
About this study
simple random sampling into group A \& group B to collect data. Group A will be given upper extremity aerobic training and group B will be given upper extremity resistance training. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, and quality of life.
Read the detailed description
A randomized clinical trial will be conducted at Multan institute of cardiology, Multan. Non probability convenient sampling technique will be applied on--patients who will be allocated through simple random sampling into group A \& group B to collect data. Group A will be given upper extremity aerobic training and group B will be given upper extremity resistance training. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, and quality of life. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Blood Pressure
- Being tested
- upper extremity aerobic training, upper extremity resistance training
- Keywords
- Cardiorespiratory Fitness, Oxygen Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper extremity aerobic trainingOther
upper extremity aerobic training \& baseline treatment will be given. Overall session time will be 40-45 minutes
upper extremity resistance trainingOther
upper extremity resistance training Overall session time will be 40-45 minutes
| Study group | Role | What they receive |
|---|---|---|
| upper extremity aerobic training | Experimental | upper extremity aerobic training Receives: Other: upper extremity aerobic training |
| upper extremity resistance training | Experimental | upper extremity resistance training Receives: Other: upper extremity resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 MWT RESISTANCE TRAINING ON CARDIORESPIRATORY FITNESS IN HYPERTENSIVE PATIENTS
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).The self-paced 6MWT assesses the submaximal level of functional capacity. (19) According to studies, the distance walked by a healthy subject on six-minute walk test ranges from 400 to 700m.
- Men ranged from 735m to 580m.
- Women ranged from 657m to 500m.
Measured: 4 weeks
Secondary outcomes (1)
Borg rating of perceived exertion (RPE)
Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. It is used in monitoring progress and mode of exercise in cardiac patients as well as in other patient populations undergoing rehabilitation and endurance training.Borg RPE scale was developed by Gunnar Borg for rating exertion and breathlessness during physical activity ; that is, how hard the activity is as shown by high heart and respiration rate , profuse perspiration and muscle exertion.
RPE scale contains 10 points (20).
- 1 denotes very light activity
- 2-3 denotes light activity
- 4-6 denotes moderate activity
- 7-8 denotes vigorous activity
- 9 denotes very hard activity
- 10 denotes maximum effort activity training.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start15 Jun 2023
- Primary completion10 Aug 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Faisal, MS.CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936892
- Sponsor's protocol ID
- REC/RCR & AHS/23/0309
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kokubo Y. Prevention of hypertension and cardiovascular diseases: a comparison of lifestyle factors in Westerners and East Asians. Hypertension. 2014 Apr;63(4):655-60. doi: 10.1161/HYPERTENSIONAHA.113.00543. Epub 2014 Jan 13. No abstract available.
PubMed 24420548Franco OH, Peeters A, Bonneux L, de Laet C. Blood pressure in adulthood and life expectancy with cardiovascular disease in men and women: life course analysis. Hypertension. 2005 Aug;46(2):280-6. doi: 10.1161/01.HYP.0000173433.67426.9b. Epub 2005 Jun 27.
PubMed 15983235Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
PubMed 30165516Smart TFF, Doleman B, Hatt J, Paul M, Toft S, Lund JN, Phillips BE. The role of resistance exercise training for improving cardiorespiratory fitness in healthy older adults: a systematic review and meta-analysis. Age Ageing. 2022 Jun 1;51(6):afac143. doi: 10.1093/ageing/afac143.
PubMed 35737600Mandsager K, Harb S, Cremer P, Phelan D, Nissen SE, Jaber W. Association of Cardiorespiratory Fitness With Long-term Mortality Among Adults Undergoing Exercise Treadmill Testing. JAMA Netw Open. 2018 Oct 5;1(6):e183605. doi: 10.1001/jamanetworkopen.2018.3605.
PubMed 30646252Khalid Z, Farheen H, Tariq MI, Amjad I. Effectiveness of resistance interval training versus aerobic interval training on peak oxygen uptake in patients with myocardial infarction. J Pak Med Assoc. 2019 Aug;69(8):1194-1198.
PubMed 31431779
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of UE Aerobic and Resistance Training on Cardiorespiratory Fitness in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05936892
- Acronym / sponsor ID
- REC/RCR & AHS/23/0309
- Conditions
- Blood Pressure
- Keywords
- Cardiorespiratory Fitness, Oxygen Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 10 Jul 2023 (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.
simple random sampling into group A \& group B to collect data. Group A will be given upper extremity aerobic training and group B will be given upper extremity resistance training. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, and quality of life.
Detailed description
A randomized clinical trial will be conducted at Multan institute of cardiology, Multan. Non probability convenient sampling technique will be applied on--patients who will be allocated through simple random sampling into group A \& group B to collect data. Group A will be given upper extremity aerobic training and group B will be given upper extremity resistance training. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, and quality of life. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upper extremity aerobic training | Experimental | Other: upper extremity aerobic trainingupper extremity aerobic training |
| upper extremity resistance training | Experimental | Other: upper extremity resistance trainingupper extremity resistance training |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age group of 35-65years
- Both male and females
- Patients with blood pressure >140/90mm Hg
Key exclusion criteria (6 listed)
- Regular engagement in physical exercise training in past 4 weeks
- Patients with secondary hypertension
- Patients using more than one hypertensive drugs
- Recent myocardial infarction
- Congestive heart failure
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 |
|---|---|---|
| upper extremity aerobic trainingupper extremity aerobic training \& baseline treatment will be given. Overall session time will be 40-45 minutes | Other | upper extremity aerobic training |
| upper extremity resistance trainingupper extremity resistance training Overall session time will be 40-45 minutes | Other | upper extremity resistance training |
Primary outcome
6 MWT RESISTANCE TRAINING ON CARDIORESPIRATORY FITNESS IN HYPERTENSIVE PATIENTS
Time frame: 4 weeks
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).The self-paced 6MWT assesses the submaximal level of functional capacity. (19) According to studies, the distance walked by a healthy subject on six-minute walk test ranges from 400 to 700m. * Men ranged from 735m to 580m. * Women ranged from 657m to 500m.
1 secondary outcome
Borg rating of perceived exertion (RPE)
Time frame: 4 weeks
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 13 Jun 2024.
- Background: PubMed 24420548Kokubo Y. Prevention of hypertension and cardiovascular diseases: a comparison of lifestyle factors in Westerners and East Asians. Hypertension. 2014 Apr;63(4):655-60. doi: 10.1161/HYPERTENSIONAHA.113.00543. Epub 2014 Jan 13. No abstract available.
- Background: PubMed 15983235Franco OH, Peeters A, Bonneux L, de Laet C. Blood pressure in adulthood and life expectancy with cardiovascular disease in men and women: life course analysis. Hypertension. 2005 Aug;46(2):280-6. doi: 10.1161/01.HYP.0000173433.67426.9b. Epub 2005 Jun 27.
- Background: PubMed 30165516Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
- Background: PubMed 35737600Smart TFF, Doleman B, Hatt J, Paul M, Toft S, Lund JN, Phillips BE. The role of resistance exercise training for improving cardiorespiratory fitness in healthy older adults: a systematic review and meta-analysis. Age Ageing. 2022 Jun 1;51(6):afac143. doi: 10.1093/ageing/afac143.
- Background: PubMed 30646252Mandsager K, Harb S, Cremer P, Phelan D, Nissen SE, Jaber W. Association of Cardiorespiratory Fitness With Long-term Mortality Among Adults Undergoing Exercise Treadmill Testing. JAMA Netw Open. 2018 Oct 5;1(6):e183605. doi: 10.1001/jamanetworkopen.2018.3605.
- Background: PubMed 31431779Khalid Z, Farheen H, Tariq MI, Amjad I. Effectiveness of resistance interval training versus aerobic interval training on peak oxygen uptake in patients with myocardial infarction. J Pak Med Assoc. 2019 Aug;69(8):1194-1198.
- 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.
Sidra Faisal, MS.CPPT 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 upper extremity aerobic training and upper extremity resistance training in people with Blood Pressure, 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 3 inclusion and 6 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 13 Jun 2024. 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?
6 MWT RESISTANCE TRAINING ON CARDIORESPIRATORY FITNESS IN HYPERTENSIVE PATIENTS (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05936892, which also lists 6 linked publications.
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 13 Jun 2024.