- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078736
Effects of Moderate Intensity Intermittent and Moderate Intensity Continuous Training on Hyperlipdemia
Effects of Moderate Intensity Intermittent Training Versus Continuous Training on Indices of Cardio-metabolic Health in Women With Hyperlipidemia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Punjab
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Sialkot, Punjab, Pakistan
- Sialkot, Milestone gym
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women.
- Age 30-40 years.
- Hyperlipidemia
Exclusion Criteria:
- With another serious cardiac condition.
- With any musculoskeletal injury.
- With any systematic condition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: moderate intensity intermittent training
baseline physical therapy treatment along with 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
|
EXPERIMENTAL: moderate intensity continuous training
baseline physical therapy treatment along with 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid profile
Time Frame: 5 weeks
|
Lipid profile (fasting triglycerides, HDL, LDL) will be done through blood samples of the participants.
|
5 weeks
|
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.
|
5th Week
|
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.
|
5th Week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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. No abstract available.
- 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.
- Alvarez 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.
- 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
- 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.
- Caballero 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.
- 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):1508. doi: 10.3390/ijerph15071508.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/0409 Shama
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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