NCT05078736

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

August 27, 2021

Last Update Submit

January 3, 2022

Conditions

Keywords

CholesterolHyperlipidemiaMICTMIIT

Outcome Measures

Primary Outcomes (3)

  • Lipid profile

    Lipid profile (fasting triglycerides, HDL, LDL) will be done through blood samples of the participants.

    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.

    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.

    5th Week

Study Arms (2)

moderate intensity intermittent training

EXPERIMENTAL

baseline physical therapy treatment along with moderate intensity intermittent training

Other: Moderate intensity intermittent training

moderate intensity continuous training

EXPERIMENTAL

baseline physical therapy treatment along with moderate intensity continuous training

Other: Moderate intensity continuous training

Interventions

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 intermittent 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.

moderate intensity continuous training

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women.
  • Age 30-40 years.
  • Hyperlipidemia

You may not qualify if:

  • With another serious cardiac condition.
  • With any musculoskeletal injury.
  • With any systematic condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sialkot, Milestone gym

Sialkot, Punjab Province, Pakistan

Location

Related Publications (12)

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

    BACKGROUND
  • 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.

    PMID: 22691586BACKGROUND
  • 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.

    PMID: 30135334BACKGROUND
  • 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.

    PMID: 26412413BACKGROUND
  • 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.

    PMID: 33195846BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 23402469BACKGROUND
  • Caballero B, Trugo LC, Finglas PM. Encyclopedia of food sciences and nutrition: Academic; 2003

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 31336492BACKGROUND
  • 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.

    PMID: 30018242BACKGROUND
  • 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.

    PMID: 32437574BACKGROUND

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Syed Shakil Ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

October 14, 2021

Study Start

August 30, 2021

Primary Completion

December 15, 2021

Study Completion

December 30, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations