The Effects of Pilates on Functional Capacity and Blood Glucose Levels in Adults With Diabetes Type 2
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
pilates exercise
brisk walk
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring glycemic control, hyperglycemia, functionality, Pilates exercises
Eligibility Criteria
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
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group-A
Group-B
Arm Description
Group-A will receive pilates exercise and standard care
Group-B will receive brisk walk and standard care
Outcomes
Primary Outcome Measures
6-minute walk test
functional capacity is checked by 6-minute walk test
HbA1c
A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05261776
First Posted
February 20, 2022
Last Updated
May 31, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05261776
Brief Title
The Effects of Pilates on Functional Capacity and Blood Glucose Levels in Adults With Diabetes Type 2
Official Title
The Effects of Pilates on Functional Capacity and Blood Glucose Levels in Adults With Diabetes Type 2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
March 27, 2022 (Actual)
Study Completion Date
April 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
glycemic control, hyperglycemia, functionality, Pilates exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The study would be single blinded as accessor of the study would be kept blind of the treatment group to which patient would be allocated. After the complete initial screening process, every recruited patient will be accessed by an independent assessor, expert will use outcome measuring tools. his will be recorded as baseline measurement assessment
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group-A
Arm Type
Experimental
Arm Description
Group-A will receive pilates exercise and standard care
Arm Title
Group-B
Arm Type
Active Comparator
Arm Description
Group-B will receive brisk walk and standard care
Intervention Type
Other
Intervention Name(s)
pilates exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
brisk walk
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-minute walk test
Description
functional capacity is checked by 6-minute walk test
Time Frame
12th week
Title
HbA1c
Description
A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin.
Time Frame
12th week
Title
Blood glucose level
Description
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
Time Frame
12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Riphah International University
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
29304014
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):78. doi: 10.3390/ijerph15010078.
Results Reference
background
PubMed Identifier
28977088
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.
Results Reference
background
PubMed Identifier
29985228
Citation
Melo KCB, Araujo FS, Cordeiro Junior 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.
Results Reference
background
PubMed Identifier
30697507
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.
Results Reference
background
PubMed Identifier
26957746
Citation
Colak TK, Acar G, Dereli EE, Ozgul B, Demirbuken I, Alkac C, 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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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-.
Results Reference
background
Citation
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).
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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The Effects of Pilates on Functional Capacity and Blood Glucose Levels in Adults With Diabetes Type 2
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