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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05261776
Other study ID # REC-FSD-00240
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date April 5, 2022

Study information

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

Clinical Trial Summary

The aim of this study is to investigate the effects of the Pilates training on Functional Capacity among adults with type 2 diabetes The aim of this study is to investigate the effects of the Pilates training on blood glucose response among adults with type 2 diabetes


Description:

A Randomized Control Trial study of 3 month period will be arranged, at Riphah International University Faisalabad after the approval of synopsis. The convenience sampling technique will be selected for registration of patients. According to specified inclusion, exclusion criteria, patients will be chosen. Calculation of Sample size for the study tells need of both males and females (45 yrs-65 yrs) that will fulfill the certain criteria. The participants of group A will receive Pilates exercise and standard care and participants of group B will receive a brisk walk on treadmill and standard care. The evaluation of patients will be done at baseline, at 6th week, 12th week and at follow up after one month of discontinuation of treatment. The patient's outcome will be measured by 6-Minute Walk Test (distance), hemoglobin A1c level and Blood Glucose level and the recording of the patient's data will be at pre-treatment and post-treatment. The data of before treatment and after treatment will be compared at follow up after one month of discontinuation of treatment. For each patient informed consent will be taken. Through Statistical Package of Social Sciences 20 software, data entry and analysis will be done


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date April 5, 2022
Est. primary completion date March 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - Diabetic patient both male and female with diagnosed with type ii diabetes - 45-65 years old - Lack of psychic disease, dementia and mental retardation Exclusion Criteria: - ulcers in extremities - Peripheral neuropathy - Severe or decompensated heart disease - Limited coronary heart disease - Insulin therapy

Study Design


Intervention

Other:
pilates exercise
Pilates exercise for 40 minutes (5 minutes for warm-up and 30 minutes of pilates and 5 minutes for cool down). These participants will continue their standard care. Patients in Group-A will get 40 minutes of session, Alternative three days/ week for 12 weeks.
brisk walk
Brisk walk on treadmill for 40 minutes (5 minutes for warm-up and 30 minutes of brisk walk on treadmill and 5 minutes for cool down). These participants will continue their standard care. Patients in Group-B of 40 minutes of session, Alternative three days/ week for 12 weeks.

Locations

Country Name City State
Pakistan Riphah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (14)

1. Zolfaghari N, Faramarzi M, Afkhami-Ardekani M, Afkhami-Ardekani A, Jam Ashkezari S. The Effect of Eight Weeks Pilates Exercise on Testosterone and Sex Hormone Biding Globulin (SHBG) in Women with Type 2 Diabetes. Iranian Journal of Diabetes and Obesity. 2015;7(2):45-9.

10. Yucel H, Uysal O. Pilates-based mat exercises and parameters of quality of life in women with Type 2 diabetes. Iranian Red Crescent Medical Journal. 2018;20(S1).

11. Hassani N, Heravi-Karimooi M, Rejeh N, Ashtiani MHD, Sharifnia H, Ghanbari M, et al. The effect of pilates exercise on quality of life of elderly women with type 2 diabetes. Payesh (Health Monitor). 2018;17(5):531-9.

12. Mir E, Fathi M. Changes in Plasma Visfatin and Insulin Resistance Index in Obese Women with Type 2 Diabetes after Pilates Exercise. Journal of Health and Care. 2018;20(1):30-9.

13. Sharma D, Kaur J, Rani M, Bansal A, Malik M, Kulandaivelan S. Efficacy of Pilates based mat exercise on quality of life, quality of sleep and satisfaction with life in type 2 diabetes mellitus. Romanian Journal of Diabetes Nutrition and Metabolic Diseases. 2018;25(2):149-56.

14. Zolfaghari N, Faramarzi M, Afkhami-Ardekani M, Afkhami-Ardekani A, Jam Ashkezari S. The Effect of Eight Weeks Pilates Exercise on Testosterone and Sex Hormone Biding Globulin (SHBG) in Women with Type 2 Diabetes. Iranian Journal of Diabetes and Obesity. 2015;7(2):45-9.

15. Ebrahimi F, Mahdavinejad R, Jalily H. The effects of selected Pilates exercises on muscle strength, balance and HbA1c in female patients with diabetes type 2. Journal of Exercise Science and Medicine. 2015;7(2):251-65.

7. Torabian M, Taghadosi M, Ajorpaz NM, Khorasanifar L. The effect of Pilates exercises on general health in women with type 2 diabetes. Life Sci J. 2013;2:1-39.

9. NESREEN G, YASMIN M, HAKEM M, SALLY A. Effect of Pilates Exercise on Cardio Metabolic Risk Factors in Women with Type 2 Diabetes. The Medical Journal of Cairo University. 2019;87(March):851-.

Çolak TK, Acar G, Dereli EE, Özgül B, Demirbüken I, Alkaç Ç, Polat MG. Association between the physical activity level and the quality of life of patients with type 2 diabetes mellitus. J Phys Ther Sci. 2016 Jan;28(1):142-7. doi: 10.1589/jpts.28.142. Epub 2016 Jan 30. — View Citation

Dendup T, Feng X, Clingan S, Astell-Burt T. Environmental Risk Factors for Developing Type 2 Diabetes Mellitus: A Systematic Review. Int J Environ Res Public Health. 2018 Jan 5;15(1). pii: E78. doi: 10.3390/ijerph15010078. Review. — View Citation

Melo KCB, Araújo FS, Cordeiro Júnior CCM, de Andrade KTP, Moreira SR. Pilates Method Training: Functional and Blood Glucose Responses of Older Women With Type 2 Diabetes. J Strength Cond Res. 2020 Apr;34(4):1001-1007. doi: 10.1519/JSC.0000000000002704. — View Citation

Nomura T, Kawae T, Kataoka H, Ikeda Y. Aging, physical activity, and diabetic complications related to loss of muscle strength in patients with type 2 diabetes. Phys Ther Res. 2018 Nov 30;21(2):33-38. doi: 10.1298/ptr.R0002. eCollection 2018. Review. — View Citation

Silva EFF, Ferreira CMM, Pinho L. Risk factors and complications in type 2 diabetes outpatients. Rev Assoc Med Bras (1992). 2017 Jul;63(7):621-627. doi: 10.1590/1806-9282.63.07.621. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 6-minute walk test functional capacity is checked by 6-minute walk test 12th week
Primary HbA1c A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin. 12th week
Primary Blood glucose level The blood glucose level is the amount of glucose in the blood. Glucose is a sugar that comes from the foods we eat, and it's also formed and stored inside the body 12th week
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