HyperlipidemiasNCT05078736
Effects of Moderate Intensity Intermittent and Moderate Intensity Continuous Training on Hyperlipdemia
A study testing Moderate intensity intermittent training and Moderate intensity continuous training in people with Hyperlipidemias, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project will be a Randomized control trial conducted to check the effects of moderate intensity intermittent training versus moderate intensity continuous training on indices of cardio-metabolic health in women with hyperlipidemia, duration will be of 5 weeks, purposive sampling data technique, will be done… Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Moderate intensity intermittent training and Moderate intensity continuous training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2021to 30 Dec 2021
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women.
- Age 30-40 years.
- Hyperlipidemia
Who cannot join
- With another serious cardiac condition.
- With any musculoskeletal injury.
- With any systematic condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Moderate Intensity Intermittent Training Versus Continuous Training on Indices of Cardio-metabolic Health in Women With Hyperlipidemia
This project will be a Randomized control trial conducted to check the effects of moderate intensity intermittent training versus moderate intensity continuous training on indices of cardio-metabolic health in women with hyperlipidemia, duration will be of 5 weeks, purposive sampling data technique, will be done, subject following eligibility criteria from milestone gym Sialkot, will randomly allocated in two groups via lottery method, baseline assessment will be done, Group A participants will receive baseline treatment along with moderate intensity intermittent training, and Group B participants will receive baseline treatment along with moderate intensity continuous training. Pre and post intervention assessment will include lipid profile test and Vo2 max rating of perceived exertion (RPE), and post data will be analyzed by using SPSS version 25.
Read the detailed description
Hyperlipidemia is a condition with high levels of fat in the blood, such as cholesterol and triglycerides. Hyperlipidemia is most commonly associated with high-fat diets, sedentary lifestyle, obesity and diabetes. The aim of the current study is to find the effectiveness of moderate intensity intermittent training and moderate intensity continuous training in women with hyperlipidemia. It will be a Randomized control trial and screening will be done as per the inclusion criteria of women having 30-40 years of age with hyperlipidemia. Participants with the history of any serious cardiac condition, musculoskeletal injury, and any type of systemic issue will be excluded.
Participants will be randomly allocated into two groups, Group A will receive moderate intensity intermittent training consist of running for 5 km with 1-min at 70% of maximal aerobic speed with interval of 1-min passive recovery and Group B will receive moderate intensity continuous training consist of running continuously for 5 km at 70% of maximal aerobic speed for 5 weeks including exercise training of 3 days/week. Participants in both groups will be assessed with Lipid profile (fasting triglycerides, High Density Lipoproteins, Low density Lipoproteins) before and after the intervention.
VO2 max, rating of perceived exertion (RPE) Step Test: The step test is designed to measure a person's aerobic fitness. Participants step up and down, on and off an aerobic- type step for three minutes to increase heart rate and evaluate the heart's recovery rate during the minute immediately following the step test exercise.
Modified Borg scale: MBS is a 0-10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administrated during six-minute walk testing.
- Conditions
- Hyperlipidemias
- Being tested
- Moderate intensity intermittent training, Moderate intensity continuous training
- Keywords
- Cholesterol, Hyperlipidemia, MICT, MIIT
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity intermittent trainingOther
In group A participants will receive moderate intensity intermittent training including running of 5 km with 1-min at 70% of maximal aerobic speed with interval of 1-min passive recovery, exercises will be performed by gym trainer for 5 weeks including 3 days/week
Moderate intensity continuous trainingOther
In group B participants will receive moderate intensity continuous training ran continuously the same 5 km at 70% of maximal aerobic speed, exercises will be performed by gym trainer for 5 weeks including 3 days/week.
| Study group | Role | What they receive |
|---|---|---|
| moderate intensity intermittent training | Experimental | baseline physical therapy treatment along with moderate intensity intermittent training Receives: Other: Moderate intensity intermittent training |
| moderate intensity continuous training | Experimental | baseline physical therapy treatment along with moderate intensity continuous training Receives: Other: Moderate intensity continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Lipid profile (fasting triglycerides, HDL, LDL) will be done through blood samples of the participants.
Measured: 5 weeks
Step Test:
The step test is designed to measure a person's aerobic fitness. Participants step up and down, on and off an aerobic- type step for three minutes to increase heart rate and evaluate the heart's and evaluate the heart's recovery rate during the minute immediately following the step test exercise.
Measured: 5th Week
Modified Borg scale
MBS is a 0-10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administrated during six-minute walk testing.
Measured: 5th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start30 Aug 2021
- Primary completion15 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies 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
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil Ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078736
- Sponsor's protocol ID
- REC/Lhr/0409 Shama
- Status last verified
- Jan 2022
- First submitted
- 27 Aug 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nirosha K, Divya M, Vamsi S, Sadiq M. A review on hyperlipidemia. International Journal of Novel Trends in PharmaceuticalSciences. 2014;4(5):81-92
Fung M, Hill J, Cook D, Frohlich J. Case series of type III hyperlipoproteinemia in children. BMJ Case Rep. 2011 Jun 9;2011:bcr0220113895. doi: 10.1136/bcr.02.2011.3895.
PubMed 22691586Kinoshita M, Yokote K, Arai H, Iida M, Ishigaki Y, Ishibashi S, Umemoto S, Egusa G, Ohmura H, Okamura T, Kihara S, Koba S, Saito I, Shoji T, Daida H, Tsukamoto K, Deguchi J, Dohi S, Dobashi K, Hamaguchi H, Hara M, Hiro T, Biro S, Fujioka Y, Maruyama C, Miyamoto Y, Murakami Y, Yokode M, Yoshida H, Rakugi H, Wakatsuki A, Yamashita S; Committee for Epidemiology and Clinical Management of Atherosclerosis. Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017. J Atheroscler Thromb. 2018 Sep 1;25(9):846-984. doi: 10.5551/jat.GL2017. Epub 2018 Aug 22. No abstract available.
PubMed 30135334Zhang ZH, Wei F, Vaziri ND, Cheng XL, Bai X, Lin RC, Zhao YY. Metabolomics insights into chronic kidney disease and modulatory effect of rhubarb against tubulointerstitial fibrosis. Sci Rep. 2015 Sep 28;5:14472. doi: 10.1038/srep14472.
PubMed 26412413Alvarez Ramirez AA, Pelaez JL, Bermudez IM, Gordon Botero JY. Prevalence of hyperlipidemia and its associated factors in university students in Colombia. Heliyon. 2020 Nov 3;6(11):e05417. doi: 10.1016/j.heliyon.2020.e05417. eCollection 2020 Nov.
PubMed 33195846Abid N, Khan SA, Taseer I. Frequency of hyperlipidemia in patients presenting with ischemic stroke. Pak J Med Health Sci. 2012;6(2):423-28
Nelson RH. Hyperlipidemia as a risk factor for cardiovascular disease. Prim Care. 2013 Mar;40(1):195-211. doi: 10.1016/j.pop.2012.11.003. Epub 2012 Dec 4.
PubMed 23402469Caballero B, Trugo LC, Finglas PM. Encyclopedia of food sciences and nutrition: Academic; 2003
Pramparo P, Boissonnet C, Schargrodsky H. Evaluation of Cardiovascular Risk in Seven Cities in Latin America: The Main Conclusions. Argentine Journal of Cardiology.79(4):368-70
Lira FS, Antunes BM, Figueiredo C, Campos EZ, Panissa VLG, St-Pierre DH, Lavoie JM, Magri-Tomaz L. Impact of 5-week high-intensity interval training on indices of cardio metabolic health in men. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1359-1364. doi: 10.1016/j.dsx.2019.02.006. Epub 2019 Feb 5.
PubMed 31336492Alansare A, Alford K, Lee S, Church T, Jung HC. The Effects of High-Intensity Interval Training vs. Moderate-Intensity Continuous Training on Heart Rate Variability in Physically Inactive Adults. Int J Environ Res Public Health. 2018 Jul 17;15(7):1508. doi: 10.3390/ijerph15071508.
PubMed 30018242Khan SU, Khan MZ, Raghu Subramanian C, Riaz H, Khan MU, Lone AN, Khan MS, Benson EM, Alkhouli M, Blaha MJ, Blumenthal RS, Gulati M, Michos ED. Participation of Women and Older Participants in Randomized Clinical Trials of Lipid-Lowering Therapies: A Systematic Review. JAMA Netw Open. 2020 May 1;3(5):e205202. doi: 10.1001/jamanetworkopen.2020.5202.
PubMed 32437574
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate Intensity Intermittent Training Versus Continuous Training on Indices of Cardio-metabolic Health in Women With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT05078736
- Acronym / sponsor ID
- REC/Lhr/0409 Shama
- Conditions
- Hyperlipidemias
- Keywords
- Cholesterol, Hyperlipidemia, MICT, MIIT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 14 Oct 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.
This project will be a Randomized control trial conducted to check the effects of moderate intensity intermittent training versus moderate intensity continuous training on indices of cardio-metabolic health in women with hyperlipidemia, duration will be of 5 weeks, purposive sampling data technique, will be done, subject following eligibility criteria from milestone gym Sialkot, will randomly allocated in two groups via lottery method, baseline assessment will be done, Group A participants will receive baseline treatment along with moderate intensity intermittent training, and Group B participants will receive baseline treatment along with moderate intensity continuous training. Pre and post intervention assessment will include lipid profile test and Vo2 max rating of perceived exertion (RPE), and post data will be analyzed by using SPSS version 25.
Detailed description
Hyperlipidemia is a condition with high levels of fat in the blood, such as cholesterol and triglycerides. Hyperlipidemia is most commonly associated with high-fat diets, sedentary lifestyle, obesity and diabetes. The aim of the current study is to find the effectiveness of moderate intensity intermittent training and moderate intensity continuous training in women with hyperlipidemia. It will be a Randomized control trial and screening will be done as per the inclusion criteria of women having 30-40 years of age with hyperlipidemia. Participants with the history of any serious cardiac condition, musculoskeletal injury, and any type of systemic issue will be excluded.
Participants will be randomly allocated into two groups, Group A will receive moderate intensity intermittent training consist of running for 5 km with 1-min at 70% of maximal aerobic speed with interval of 1-min passive recovery and Group B will receive moderate intensity continuous training consist of running continuously for 5 km at 70% of maximal aerobic speed for 5 weeks including exercise training of 3 days/week. Participants in both groups will be assessed with Lipid profile (fasting triglycerides, High Density Lipoproteins, Low density Lipoproteins) before and after the intervention.
VO2 max, rating of perceived exertion (RPE) Step Test: The step test is designed to measure a person's aerobic fitness. Participants step up and down, on and off an aerobic- type step for three minutes to increase heart rate and evaluate the heart's recovery rate during the minute immediately following the step test exercise.
Modified Borg scale: MBS is a 0-10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administrated during six-minute walk testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate intensity intermittent training | Experimental | Other: Moderate intensity intermittent trainingbaseline physical therapy treatment along with moderate intensity intermittent training |
| moderate intensity continuous training | Experimental | Other: Moderate intensity continuous trainingbaseline physical therapy treatment along with moderate intensity continuous training |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women.
- Age 30-40 years.
- Hyperlipidemia
Key exclusion criteria (3 listed)
- With another serious cardiac condition.
- With any musculoskeletal injury.
- With any systematic condition.
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 |
|---|---|---|
| Moderate intensity intermittent trainingIn group A participants will receive moderate intensity intermittent training including running of 5 km with 1-min at 70% of maximal aerobic speed with interval of 1-min passive recovery, exercises will be performed by gym trainer for 5 weeks including 3 days/week | Other | moderate intensity intermittent training |
| Moderate intensity continuous trainingIn group B participants will receive moderate intensity continuous training ran continuously the same 5 km at 70% of maximal aerobic speed, exercises will be performed by gym trainer for 5 weeks including 3 days/week. | Other | moderate intensity continuous training |
Primary outcome
Lipid profile
Time frame: 5 weeks
Lipid profile (fasting triglycerides, HDL, LDL) will be done through blood samples of the participants.
Step Test:
Time frame: 5th Week
The step test is designed to measure a person's aerobic fitness. Participants step up and down, on and off an aerobic- type step for three minutes to increase heart rate and evaluate the heart's and evaluate the heart's recovery rate during the minute immediately following the step test exercise.
Modified Borg scale
Time frame: 5th Week
MBS is a 0-10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administrated during six-minute walk testing.
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 4 Jan 2022.
- BackgroundNirosha K, Divya M, Vamsi S, Sadiq M. A review on hyperlipidemia. International Journal of Novel Trends in PharmaceuticalSciences. 2014;4(5):81-92
- Background: PubMed 22691586Fung M, Hill J, Cook D, Frohlich J. Case series of type III hyperlipoproteinemia in children. BMJ Case Rep. 2011 Jun 9;2011:bcr0220113895. doi: 10.1136/bcr.02.2011.3895.
- Background: PubMed 30135334Kinoshita M, Yokote K, Arai H, Iida M, Ishigaki Y, Ishibashi S, Umemoto S, Egusa G, Ohmura H, Okamura T, Kihara S, Koba S, Saito I, Shoji T, Daida H, Tsukamoto K, Deguchi J, Dohi S, Dobashi K, Hamaguchi H, Hara M, Hiro T, Biro S, Fujioka Y, Maruyama C, Miyamoto Y, Murakami Y, Yokode M, Yoshida H, Rakugi H, Wakatsuki A, Yamashita S; Committee for Epidemiology and Clinical Management of Atherosclerosis. Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017. J Atheroscler Thromb. 2018 Sep 1;25(9):846-984. doi: 10.5551/jat.GL2017. Epub 2018 Aug 22. No abstract available.
- Background: PubMed 26412413Zhang ZH, Wei F, Vaziri ND, Cheng XL, Bai X, Lin RC, Zhao YY. Metabolomics insights into chronic kidney disease and modulatory effect of rhubarb against tubulointerstitial fibrosis. Sci Rep. 2015 Sep 28;5:14472. doi: 10.1038/srep14472.
- Background: PubMed 33195846Alvarez Ramirez AA, Pelaez JL, Bermudez IM, Gordon Botero JY. Prevalence of hyperlipidemia and its associated factors in university students in Colombia. Heliyon. 2020 Nov 3;6(11):e05417. doi: 10.1016/j.heliyon.2020.e05417. eCollection 2020 Nov.
- BackgroundAbid N, Khan SA, Taseer I. Frequency of hyperlipidemia in patients presenting with ischemic stroke. Pak J Med Health Sci. 2012;6(2):423-28
- Background: PubMed 23402469Nelson RH. Hyperlipidemia as a risk factor for cardiovascular disease. Prim Care. 2013 Mar;40(1):195-211. doi: 10.1016/j.pop.2012.11.003. Epub 2012 Dec 4.
- BackgroundCaballero B, Trugo LC, Finglas PM. Encyclopedia of food sciences and nutrition: Academic; 2003
- BackgroundPramparo P, Boissonnet C, Schargrodsky H. Evaluation of Cardiovascular Risk in Seven Cities in Latin America: The Main Conclusions. Argentine Journal of Cardiology.79(4):368-70
- Background: PubMed 31336492Lira FS, Antunes BM, Figueiredo C, Campos EZ, Panissa VLG, St-Pierre DH, Lavoie JM, Magri-Tomaz L. Impact of 5-week high-intensity interval training on indices of cardio metabolic health in men. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1359-1364. doi: 10.1016/j.dsx.2019.02.006. Epub 2019 Feb 5.
- Background: PubMed 30018242Alansare A, Alford K, Lee S, Church T, Jung HC. The Effects of High-Intensity Interval Training vs. Moderate-Intensity Continuous Training on Heart Rate Variability in Physically Inactive Adults. Int J Environ Res Public Health. 2018 Jul 17;15(7):1508. doi: 10.3390/ijerph15071508.
- Background: PubMed 32437574Khan SU, Khan MZ, Raghu Subramanian C, Riaz H, Khan MU, Lone AN, Khan MS, Benson EM, Alkhouli M, Blaha MJ, Blumenthal RS, Gulati M, Michos ED. Participation of Women and Older Participants in Randomized Clinical Trials of Lipid-Lowering Therapies: A Systematic Review. JAMA Netw Open. 2020 May 1;3(5):e205202. doi: 10.1001/jamanetworkopen.2020.5202.
- 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.
Syed Shakil Ur Rehman 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 Moderate intensity intermittent training and Moderate intensity continuous training in people with Hyperlipidemias, 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 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 4 Jan 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?
Lipid profile (time frame: 5 weeks). The study lists 3 primary outcomes in all. 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 NCT05078736, which also lists 12 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 4 Jan 2022.