NCT04790526

Brief Summary

The major aim of this project to check the dose response of eccentric exercise in reduction of glycemic index in type II Diabetes Mellitus. This study aim to check the effect of eccentric exercises on Glycemic index, quality of life, strength, exertion, balance and proprioception in type II Diabetes Mellitus patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration 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

March 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

March 7, 2021

Last Update Submit

July 7, 2023

Conditions

Type II Diabetes Mellitus

Keywords

Dose responseEccentric exerciseType II Diabetes MellitusGlycemic index

Outcome Measures

Primary Outcomes (2)

  • Glucometer

    Glucometer will use to monitor glucose before and after the intervention. Glucometer have poor validity and reliability but consider medical tool for the management of diabetes.

    12 week

  • HBA1c

    The A1C test is the most common diagnostic and screening tool used for Type II Diabetes Mellitus (T2DM) management and research

    0 week and 12th week

Secondary Outcomes (6)

  • WHO-QOL (BREF-Urdu version)

    0 week,4th week,8th week and 12th week

  • Six Minutes' Walk Test

    0 week,4th week,8th week and 12th week

  • Dynamometer

    0 week,4th week,8th week and 12th week

  • Borg's Exertion Scale

    0 week,4th week,8th week and 12th week

  • BERG Balance Scale

    0 week,4th week,8th week and 12th week

  • +1 more secondary outcomes

Study Arms (4)

Group A

EXPERIMENTAL

This group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks.

Other: Eccentric Exercises Dose

Group B

EXPERIMENTAL

This group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks.

Other: Eccentric Exercises Dose

Group C

EXPERIMENTAL

This group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks.

Other: Eccentric Exercises Dose

Group D

EXPERIMENTAL

This group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks.

Other: Eccentric Exercises Dose

Interventions

Eccentric Exercises DoseOTHER

Eccentric exercise will be done treadmill in control environment. The treadmill will be declined to 16 degree and 3 sessions of 10 minutes duration will be given wit 1 minute of rest in each session. 10 minutes of warm up and cool down session will be given that includes stretching and stationary bicycle with out any resistance

Group AGroup BGroup CGroup D

Eligibility Criteria

Age45 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPatient with Type II Diabetes Mellitus
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cleared by a general practitioner to attend the training program Sedentary patients with controlled type 2 diabetes, according to the definition of the American Diabetes Association.
  • Participants were untrained and had not engaged in resistance or aerobic exercise within 6 months prior to beginning the study.
  • Age between 45-65 Years. BMI should be 18.5-34.9 kg/m2.

You may not qualify if:

  • Participants with GIT disturbance (Gastroparesis and non-alcoholic fatty liver disease) will be excluded from the study.
  • Participants with any kind of Musculo-skeletal injury will be excluded from the study.
  • Participants with Stage II hypertension according to AHA guidelines. Participants who use tobacco products within the previous 6 months. Participants who take any type of systematic medication within the previous 6 months except diabetes.
  • Participants with any symptoms of neuropathy, retinopathy or nephropathy will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Department, PSRD Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (26)

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    PMID: 35914061BACKGROUND

  • NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.

    PMID: 27061677BACKGROUND

  • Holman N, Young B, Gadsby R. Current prevalence of Type 1 and Type 2 diabetes in adults and children in the UK. Diabet Med. 2015 Sep;32(9):1119-20. doi: 10.1111/dme.12791. No abstract available.

    PMID: 25962518BACKGROUND

  • Bruno G, Runzo C, Cavallo-Perin P, Merletti F, Rivetti M, Pinach S, Novelli G, Trovati M, Cerutti F, Pagano G; Piedmont Study Group for Diabetes Epidemiology. Incidence of type 1 and type 2 diabetes in adults aged 30-49 years: the population-based registry in the province of Turin, Italy. Diabetes Care. 2005 Nov;28(11):2613-9. doi: 10.2337/diacare.28.11.2613.

    PMID: 16249528BACKGROUND

  • Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.

    PMID: 17132052BACKGROUND

  • The Federal Ministry of Health and Women, Division IV (2006) European Union conference on prevention of type 2 diabetes, Vienna.

    BACKGROUND

  • Ogurtsova K, da Rocha Fernandes JD, Huang Y, Linnenkamp U, Guariguata L, Cho NH, Cavan D, Shaw JE, Makaroff LE. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017 Jun;128:40-50. doi: 10.1016/j.diabres.2017.03.024. Epub 2017 Mar 31.

    PMID: 28437734BACKGROUND

  • Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.

    PMID: 19896746BACKGROUND

  • Basit A, Fawwad A, Qureshi H, Shera AS; NDSP Members. Prevalence of diabetes, pre-diabetes and associated risk factors: second National Diabetes Survey of Pakistan (NDSP), 2016-2017. BMJ Open. 2018 Aug 5;8(8):e020961. doi: 10.1136/bmjopen-2017-020961.

    PMID: 30082350BACKGROUND

  • Chatterjee S, Khunti K, Davies MJ. Type 2 diabetes. Lancet. 2017 Jun 3;389(10085):2239-2251. doi: 10.1016/S0140-6736(17)30058-2. Epub 2017 Feb 10.

    PMID: 28190580BACKGROUND

  • O'Rahilly S. Human genetics illuminates the paths to metabolic disease. Nature. 2009 Nov 19;462(7271):307-14. doi: 10.1038/nature08532.

    PMID: 19924209BACKGROUND

  • Sui X, Hooker SP, Lee IM, Church TS, Colabianchi N, Lee CD, Blair SN. A prospective study of cardiorespiratory fitness and risk of type 2 diabetes in women. Diabetes Care. 2008 Mar;31(3):550-5. doi: 10.2337/dc07-1870. Epub 2007 Dec 10.

    PMID: 18070999BACKGROUND

  • Misra A, Vikram NK, Sharma R, Basit A. High prevalence of obesity and associated risk factors in urban children in India and Pakistan highlights immediate need to initiate primary prevention program for diabetes and coronary heart disease in schools. Diabetes Res Clin Pract. 2006 Jan;71(1):101-2. doi: 10.1016/j.diabres.2005.06.006. Epub 2005 Aug 19. No abstract available.

    PMID: 16112243BACKGROUND

  • Chen L, Pei JH, Kuang J, Chen HM, Chen Z, Li ZW, Yang HZ. Effect of lifestyle intervention in patients with type 2 diabetes: a meta-analysis. Metabolism. 2015 Feb;64(2):338-47. doi: 10.1016/j.metabol.2014.10.018. Epub 2014 Oct 23.

    PMID: 25467842BACKGROUND

  • Mitrakou A, Ryan C, Veneman T, Mokan M, Jenssen T, Kiss I, Durrant J, Cryer P, Gerich J. Hierarchy of glycemic thresholds for counterregulatory hormone secretion, symptoms, and cerebral dysfunction. Am J Physiol. 1991 Jan;260(1 Pt 1):E67-74. doi: 10.1152/ajpendo.1991.260.1.E67.

    PMID: 1987794BACKGROUND

  • King P, Macdonald IA: Normal glucose metabolism and response to hypoglycaemia. In Hypoglycaemia in Clinical Diabetes. Frier BM, Fisher BM, Eds. Chichester, U.K., John Wiley and Sons, 1999, p. 29-54.

    BACKGROUND

  • Fanelli C, Pampanelli S, Epifano L, Rambotti AM, Di Vincenzo A, Modarelli F, Ciofetta M, Lepore M, Annibale B, Torlone E, et al. Long-term recovery from unawareness, deficient counterregulation and lack of cognitive dysfunction during hypoglycaemia, following institution of rational, intensive insulin therapy in IDDM. Diabetologia. 1994 Dec;37(12):1265-76. doi: 10.1007/BF00399801.

    PMID: 7895957BACKGROUND

  • Nishitani M, Shimada K, Sunayama S, Masaki Y, Kume A, Fukao K, Sai E, Yamashita H, Ohmura H, Onishi T, Shioya M, Sato H, Shimada A, Yamamoto T, Amano A, Daida H. Impact of diabetes on muscle mass, muscle strength, and exercise tolerance in patients after coronary artery bypass grafting. J Cardiol. 2011 Sep;58(2):173-80. doi: 10.1016/j.jjcc.2011.05.001. Epub 2011 Jul 13.

    PMID: 21741799BACKGROUND

  • Anton SD, Karabetian C, Naugle K, Buford TW. Obesity and diabetes as accelerators of functional decline: can lifestyle interventions maintain functional status in high risk older adults? Exp Gerontol. 2013 Sep;48(9):888-97. doi: 10.1016/j.exger.2013.06.007. Epub 2013 Jul 4.

    PMID: 23832077BACKGROUND

  • GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.

    PMID: 25530442BACKGROUND

  • Roglic G, Unwin N. Mortality attributable to diabetes: estimates for the year 2010. Diabetes Res Clin Pract. 2010 Jan;87(1):15-9. doi: 10.1016/j.diabres.2009.10.006. Epub 2009 Nov 14.

    PMID: 19914728BACKGROUND

  • Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7.

    PMID: 26063472BACKGROUND

  • GBD 2015 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1659-1724. doi: 10.1016/S0140-6736(16)31679-8.

    PMID: 27733284BACKGROUND

  • Rubin RJ, Altman WM, Mendelson DN. Health care expenditures for people with diabetes mellitus, 1992. J Clin Endocrinol Metab. 1994 Apr;78(4):809A-809F. doi: 10.1210/jcem.78.4.8157701.

    PMID: 8157701BACKGROUND

  • Kong AP, Xu G, Brown N, So WY, Ma RC, Chan JC. Diabetes and its comorbidities--where East meets West. Nat Rev Endocrinol. 2013 Sep;9(9):537-47. doi: 10.1038/nrendo.2013.102. Epub 2013 May 28.

    PMID: 23712250BACKGROUND

  • Hussain M, Naqvi SB, Khan MA, Rizvi M, Alam S, Abbas A, Akram MU. Direct cost of treatment of diabetes mellitus type 2 in Pakistan. Int J Pharm Pharm Sci. 2014;6(11):261-4.

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • M Faheem Afzal, *PhD

    Lahore Medical and Dental College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2021

First Posted

March 10, 2021

Study Start

July 12, 2021

Primary Completion

March 30, 2023

Study Completion

May 25, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)