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Type 2 Diabetes MellitusNCT05261776

The Effects of Pilates on Functional Capacity and Blood Glucose Levels in Adults With Diabetes Type 2

A study testing pilates exercise and brisk walk in people with Type 2 Diabetes Mellitus, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
pilates exercise and brisk walk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 sitePakistan
Study dates
15 Mar 2021to 5 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diabetic patient both male and female with diagnosed with type ii diabetes
  • 45-65 years old
  • Lack of psychic disease, dementia and mental retardation

Who cannot join

  • ulcers in extremities
  • Peripheral neuropathy
  • Severe or decompensated heart disease
  • Limited coronary heart disease
  • Insulin therapy

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah International University

    Faisalābad, Punjab Province, 38000

Other trials in Pakistan

About this study

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

Read the 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

Being tested
pilates exercise, brisk walk
Keywords
glycemic control, hyperglycemia, functionality, Pilates exercises
Medical subject headings
Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pilates exerciseOther

    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 walkOther

    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.

Study groups in NCT05261776
Study groupRoleWhat they receive
Group-AExperimentalGroup-A will receive pilates exercise and standard care
Receives: Other: pilates exercise
Group-BActive comparatorGroup-B will receive brisk walk and standard care
Receives: Other: brisk walk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-minute walk test

    functional capacity is checked by 6-minute walk test

    Measured: 12th week

  2. HbA1c

    A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin.

    Measured: 12th week

  3. 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

    Measured: 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start15 Mar 2021
  3. Primary completion27 Mar 2022
  4. Study completion5 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05261776
Sponsor's protocol ID
REC-FSD-00240
Status last verified
May 2022
First submitted
20 Feb 2022
Last updated
1 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 29304014

  • 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.

    PubMed 28977088

  • 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.

    PubMed 29985228

  • 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.

    PubMed 30697507

  • 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.

    PubMed 26957746

  • 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-.

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing pilates exercise and brisk walk in people with Type 2 Diabetes Mellitus, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute walk test (time frame: 12th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05261776, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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