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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05078736
Other study ID # REC/Lhr/0409 Shama
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2021
Est. completion date December 30, 2021

Study information

Verified date January 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 30, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 40 Years
Eligibility Inclusion Criteria: - Women. - Age 30-40 years. - Hyperlipidemia Exclusion Criteria: - With another serious cardiac condition. - With any musculoskeletal injury. - With any systematic condition.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Moderate intensity intermittent training
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 training
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.

Locations

Country Name City State
Pakistan Sialkot, Milestone gym Sialkot Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

Abid N, Khan SA, Taseer I. Frequency of hyperlipidemia in patients presenting with ischemic stroke. Pak J Med Health Sci. 2012;6(2):423-28

Alansare 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). pii: E1508. doi: 10.3390/ijerph15071508. — View Citation

Álvarez Ramírez AA, Peláez JL, Bermúdez 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. — View Citation

Caballero B, Trugo LC, Finglas PM. Encyclopedia of food sciences and nutrition: Academic; 2003

Fung M, Hill J, Cook D, Frohlich J. Case series of type III hyperlipoproteinemia in children. BMJ Case Rep. 2011 Jun 9;2011. pii: bcr0220113895. doi: 10.1136/bcr.02.2011.3895. — View Citation

Khan 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. — View Citation

Kinoshita 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. — View Citation

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. — View Citation

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. Review. — View Citation

Nirosha K, Divya M, Vamsi S, Sadiq M. A review on hyperlipidemia. International Journal of Novel Trends in PharmaceuticalSciences. 2014;4(5):81-92

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

Zhang 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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Lipid profile Lipid profile (fasting triglycerides, HDL, LDL) will be done through blood samples of the participants. 5 weeks
Primary 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. 5th Week
Primary 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. 5th Week
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