Diabetes Mellitus, Type 2NCT04732611
Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus
A study testing Pilates exercises and Walking protocol in people with Diabetes Mellitus, Type 2, run by Federal University of Rio Grande do Sul.
Trial summary
The Diabetes Mellitus (DM) is a major worldwide public health problem. The hyperglycemia resulting from DM could lead to metabolic adaptations and physiological changes in different body systems. The DM patients are usually sedentary, once the symptoms as the sensory deficits compromise balance and gait. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Pilates exercises and Walking protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Aug 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 35 and 65 years old;
- Possess type 2 diabetes mellitus diagnosed;
- Medical approval to practice exercise;
- Do not have any bone, joint or muscle disease that make impossible do the exercises;
- not being pregnant;
- not being unable to follow the instructions for any reason;
- not be exercising for at least 6 months.
Who cannot join
- Incapacity to follow the instructions for any reason;
- Beginning another treatment for DM2, either physical therapy, exercises or changes of the medical care throughout the study period.
- Having practiced exercises in the last six months;
- Pregnancy;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus: Randomized Clinical Trial
The Diabetes Mellitus (DM) is a major worldwide public health problem. The hyperglycemia resulting from DM could lead to metabolic adaptations and physiological changes in different body systems. The DM patients are usually sedentary, once the symptoms as the sensory deficits compromise balance and gait. Giving that this sedentary lifestyle needs to be reversed, since physical exercise is well known a fundamental element in the treatment and prevention of the DM.
The major recommendations to this population is the practice of aerobic exercises and the strength training focused on the biggest muscle groups. It is well know that this type of exercise can improve the uptake of intramuscular glucose. In that context the Pilates Method seems as a good option of exercise, once the method works in a global way, working on different muscle groups in the same exercise. Besides that, to the best of our knowledge there aren't enough studies to support the Pilates Method as an alternative type exercise to help in the glycemic control and in the management of this kind of patients. The aim of this study is to evaluate the efficacy and safety of an exercise program using the Pilates Method versus a walking program in neuromuscular, metabolic and vascular variables in type 2 diabetic patients.
Read more
60 participants will be recruited by convenience. Individuals will be eligible if [1] they had type 2 diabetes mellitus; [2] men and women aged 35 to 60 years [3] medical approval to practice exercise; [4] do not have any bone, joint or muscle disease that make the practice of exercises impossible; [5] not being pregnant; [6] not being unable to follow the instructions for any reason and [7] at least 6 months without exercising. The participants' eligibility will be checked by the researcher. Subsequently, they will be allocated randomly in one of the two groups (Pilates Group or Walking).
Pilates group participants will perform 3 Pilates sessions a week lasting approximately 50 minutes for 20 weeks. Walking group participants will perform 3 walking sessions a week lasting approximately 50 minutes for 20 weeks. All the exercises sessions will be supervised by a professional.
All the participants will be evaluated at the baseline and after 20 weeks of exercises. The main outcome of this study are the Triceps surae muscle force and the blood glycose. The secondary outcomes are Triceps surae muscle architecture, mechanical adaptations of the Achilles tendon and endothelial function.
Our hypothesis is that both groups will be safety and efficiency to improve the Triceps surae muscle force and to decrease blood glycose. Our secondary hypothesis is that the Pilates Group will show better results to both primary outcomes than the walking group.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Pilates exercises, Walking protocol
- Keywords
- Pilates, Walking, Neuromuscular Adaptation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.
Walking protocolOther
Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Experimental | Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks. Receives: Other: Pilates exercises |
| Walking | Active comparator | Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks Receives: Other: Walking protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triceps surae muscle force
Triceps surae muscle force assessed by isokinetic dynamometry.
Measured: 20 weeks
Blood Glycose
Blood Glycose assessed by HbA1c
Measured: 20 weeks
Secondary outcomes (3)
Triceps surae muscle architecture
Triceps surae muscle architecture assessed by ultrasound
Measured: 20 weeks
Mechanical adaptations of the Achilles tendon
Mechanical adaptations of the Achilles tendon assessed by ultrasound
Measured: 20 weeks
Endothelial function
Endothelial function assessed by ultrasound
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jefferson Fagundes Loss, Federal University of Rio Grande do Sul
- Investigators
- Jefferson F Loss, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732611
- Sponsor's protocol ID
- 39137
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akashi PM, Sacco IC, Watari R, Hennig E. The effect of diabetic neuropathy and previous foot ulceration in EMG and ground reaction forces during gait. Clin Biomech (Bristol). 2008 Jun;23(5):584-92. doi: 10.1016/j.clinbiomech.2007.11.015. Epub 2008 Feb 21.
PubMed 18178296American College of Sports Medicine. Diretrizes do ACSM para os testes de esforço e sua prescrição. 9 ed. - Rio de Janeiro: Guanabara, 2017
Andersen H, Nielsen S, Mogensen CE, Jakobsen J. Muscle strength in type 2 diabetes. Diabetes. 2004 Jun;53(6):1543-8. doi: 10.2337/diabetes.53.6.1543.
PubMed 15161759Arya S, Kulig K. Tendinopathy alters mechanical and material properties of the Achilles tendon. J Appl Physiol (1985). 2010 Mar;108(3):670-5. doi: 10.1152/japplphysiol.00259.2009. Epub 2009 Nov 5.
PubMed 19892931Bacarin TA, Sacco IC, Hennig EM. Plantar pressure distribution patterns during gait in diabetic neuropathy patients with a history of foot ulcers. Clinics (Sao Paulo). 2009;64(2):113-20. doi: 10.1590/s1807-59322009000200008.
PubMed 19219316Baroni BM, Geremia JM, Rodrigues R, De Azevedo Franke R, Karamanidis K, Vaz MA. Muscle architecture adaptations to knee extensor eccentric training: rectus femoris vs. vastus lateralis. Muscle Nerve. 2013 Oct;48(4):498-506. doi: 10.1002/mus.23785. Epub 2013 Jul 15.
PubMed 23852989Batista F, Nery C, Pinzur M, Monteiro AC, de Souza EF, Felippe FH, Alcantara MC, Campos RS. Achilles tendinopathy in diabetes mellitus. Foot Ankle Int. 2008 May;29(5):498-501. doi: 10.3113/FAI-2008-0498.
PubMed 18510903Bayat F, Shojaeezadeh D, Baikpour M, Heshmat R, Baikpour M, Hosseini M. The effects of education based on extended health belief model in type 2 diabetic patients: a randomized controlled trial. J Diabetes Metab Disord. 2013 Oct 28;12(1):45. doi: 10.1186/2251-6581-12-45.
PubMed 24517170Bland's, M. (2009).
Blazevich AJ. Effects of physical training and detraining, immobilisation, growth and aging on human fascicle geometry. Sports Med. 2006;36(12):1003-17. doi: 10.2165/00007256-200636120-00002.
PubMed 17123325Caselli A, Pham H, Giurini JM, Armstrong DG, Veves A. The forefoot-to-rearfoot plantar pressure ratio is increased in severe diabetic neuropathy and can predict foot ulceration. Diabetes Care. 2002 Jun;25(6):1066-71. doi: 10.2337/diacare.25.6.1066.
PubMed 12032116Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care. 2010 Dec;33(12):2692-6. doi: 10.2337/dc10-1548. No abstract available.
PubMed 21115771Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.
PubMed 11788217SILVA, N. R.; COSTA, C. E. M. A hiperglicemia e os mecanismos envolvidos nas disfunções vasculares do Diabetes Mellitus. Arq. Ciênc.Saúde Unipar, Umuarama, v. 12, n. 3, p. 265-270, set./dez. 2008
Dekerle J, Baron B, Dupont L, Vanvelcenaher J, Pelayo P. Maximal lactate steady state, respiratory compensation threshold and critical power. Eur J Appl Physiol. 2003 May;89(3-4):281-8. doi: 10.1007/s00421-002-0786-y. Epub 2003 Mar 4.
PubMed 12736836
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04732611
- Acronym / sponsor ID
- 39137
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Pilates, Walking, Neuromuscular Adaptation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Diabetes Mellitus (DM) is a major worldwide public health problem. The hyperglycemia resulting from DM could lead to metabolic adaptations and physiological changes in different body systems. The DM patients are usually sedentary, once the symptoms as the sensory deficits compromise balance and gait. Giving that this sedentary lifestyle needs to be reversed, since physical exercise is well known a fundamental element in the treatment and prevention of the DM.
The major recommendations to this population is the practice of aerobic exercises and the strength training focused on the biggest muscle groups. It is well know that this type of exercise can improve the uptake of intramuscular glucose. In that context the Pilates Method seems as a good option of exercise, once the method works in a global way, working on different muscle groups in the same exercise. Besides that, to the best of our knowledge there aren't enough studies to support the Pilates Method as an alternative type exercise to help in the glycemic control and in the management of this kind of patients. The aim of this study is to evaluate the efficacy and safety of an exercise program using the Pilates Method versus a walking program in neuromuscular, metabolic and vascular variables in type 2 diabetic patients.
60 participants will be recruited by convenience. Individuals will be eligible if [1] they had type 2 diabetes mellitus; [2] men and women aged 35 to 60 years [3] medical approval to practice exercise; [4] do not have any bone, joint or muscle disease that make the practice of exercises impossible; [5] not being pregnant; [6] not being unable to follow the instructions for any reason and [7] at least 6 months without exercising. The participants' eligibility will be checked by the researcher. Subsequently, they will be allocated randomly in one of the two groups (Pilates Group or Walking).
Pilates group participants will perform 3 Pilates sessions a week lasting approximately 50 minutes for 20 weeks. Walking group participants will perform 3 walking sessions a week lasting approximately 50 minutes for 20 weeks. All the exercises sessions will be supervised by a professional.
All the participants will be evaluated at the baseline and after 20 weeks of exercises. The main outcome of this study are the Triceps surae muscle force and the blood glycose. The secondary outcomes are Triceps surae muscle architecture, mechanical adaptations of the Achilles tendon and endothelial function.
Our hypothesis is that both groups will be safety and efficiency to improve the Triceps surae muscle force and to decrease blood glycose. Our secondary hypothesis is that the Pilates Group will show better results to both primary outcomes than the walking group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates | Experimental | Other: Pilates exercisesPilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks. |
| Walking | Active comparator | Other: Walking protocolWalking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women between 35 and 65 years old;
- Possess type 2 diabetes mellitus diagnosed;
- Medical approval to practice exercise;
- Do not have any bone, joint or muscle disease that make impossible do the exercises;
- not being pregnant;
Key exclusion criteria (4 listed)
- Incapacity to follow the instructions for any reason;
- Beginning another treatment for DM2, either physical therapy, exercises or changes of the medical care throughout the study period.
- Having practiced exercises in the last six months;
- Pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercisesPilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks. | Other | Pilates |
| Walking protocolWalking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks. | Other | Walking |
Primary outcome
Triceps surae muscle force
Time frame: 20 weeks
Triceps surae muscle force assessed by isokinetic dynamometry.
Blood Glycose
Time frame: 20 weeks
Blood Glycose assessed by HbA1c
3 secondary outcomes
Triceps surae muscle architecture
Time frame: 20 weeks
Mechanical adaptations of the Achilles tendon
Time frame: 20 weeks
Endothelial function
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Background: PubMed 18178296Akashi PM, Sacco IC, Watari R, Hennig E. The effect of diabetic neuropathy and previous foot ulceration in EMG and ground reaction forces during gait. Clin Biomech (Bristol). 2008 Jun;23(5):584-92. doi: 10.1016/j.clinbiomech.2007.11.015. Epub 2008 Feb 21.
- BackgroundAmerican College of Sports Medicine. Diretrizes do ACSM para os testes de esforço e sua prescrição. 9 ed. - Rio de Janeiro: Guanabara, 2017
- Background: PubMed 15161759Andersen H, Nielsen S, Mogensen CE, Jakobsen J. Muscle strength in type 2 diabetes. Diabetes. 2004 Jun;53(6):1543-8. doi: 10.2337/diabetes.53.6.1543.
- Background: PubMed 19892931Arya S, Kulig K. Tendinopathy alters mechanical and material properties of the Achilles tendon. J Appl Physiol (1985). 2010 Mar;108(3):670-5. doi: 10.1152/japplphysiol.00259.2009. Epub 2009 Nov 5.
- Background: PubMed 19219316Bacarin TA, Sacco IC, Hennig EM. Plantar pressure distribution patterns during gait in diabetic neuropathy patients with a history of foot ulcers. Clinics (Sao Paulo). 2009;64(2):113-20. doi: 10.1590/s1807-59322009000200008.
- Background: PubMed 23852989Baroni BM, Geremia JM, Rodrigues R, De Azevedo Franke R, Karamanidis K, Vaz MA. Muscle architecture adaptations to knee extensor eccentric training: rectus femoris vs. vastus lateralis. Muscle Nerve. 2013 Oct;48(4):498-506. doi: 10.1002/mus.23785. Epub 2013 Jul 15.
- Background: PubMed 18510903Batista F, Nery C, Pinzur M, Monteiro AC, de Souza EF, Felippe FH, Alcantara MC, Campos RS. Achilles tendinopathy in diabetes mellitus. Foot Ankle Int. 2008 May;29(5):498-501. doi: 10.3113/FAI-2008-0498.
- Background: PubMed 24517170Bayat F, Shojaeezadeh D, Baikpour M, Heshmat R, Baikpour M, Hosseini M. The effects of education based on extended health belief model in type 2 diabetic patients: a randomized controlled trial. J Diabetes Metab Disord. 2013 Oct 28;12(1):45. doi: 10.1186/2251-6581-12-45.
- BackgroundBland's, M. (2009).
- Background: PubMed 17123325Blazevich AJ. Effects of physical training and detraining, immobilisation, growth and aging on human fascicle geometry. Sports Med. 2006;36(12):1003-17. doi: 10.2165/00007256-200636120-00002.
- Background: PubMed 12032116Caselli A, Pham H, Giurini JM, Armstrong DG, Veves A. The forefoot-to-rearfoot plantar pressure ratio is increased in severe diabetic neuropathy and can predict foot ulceration. Diabetes Care. 2002 Jun;25(6):1066-71. doi: 10.2337/diacare.25.6.1066.
- Background: PubMed 21115771Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care. 2010 Dec;33(12):2692-6. doi: 10.2337/dc10-1548. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jefferson F Loss, PhD principal investigator
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises and Walking protocol in people with Diabetes Mellitus, Type 2, run by Federal University of Rio Grande do Sul.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edgar Santiago Wagner Neto, Ms (+55 51 984419763, edgar.swagner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triceps surae muscle force (time frame: 20 weeks). The study lists 2 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 NCT04732611, which also lists 56 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 Feb 2021.