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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04952948
Other study ID # 4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 23, 2016
Est. completion date December 19, 2016

Study information

Verified date July 2021
Source Universidade Federal do vale do São Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Type 2 diabetes mellitus (T2D) is a chronic inflammatory disease that is associated with loss of functional capacity and increased blood pressure. Coupled with this, there is an increased risk of falls and fractures in patients with T2D. On the other hand, conventional training programs for resistance, aerobic or combined exercises are strongly recommended for people with T2D, as they promote a reduction in the glycemic rate and blood pressure, and an improvement in functional capacity. However, little is known about unconventional training programs such as PILATES (dynamic and isometric muscle actions) on functional capacity and cardiovascular adaptations in T2D.


Description:

Type 2 diabetes mellitus (T2D) is a chronic inflammatory disease whose main mechanism of installation is insulin resistance and is associated with loss of functional capacity with consequent fragility and increased blood pressure. Currently, women have the highest prevalence of T2D in Brazil. Previous studies have shown that women are more affected by cases of hospitalization and that they have a higher risk of mortality due to illness. Muscle function and strength in patients with T2D show a reduction compared to healthy and normoglycemic subjects, especially in menopausal women, when estrogen declines with a consequent increase in body fat and decreased muscle quality. Coupled with this, there is a reduction in muscle mass and an increased risk of falls and fractures in patients with T2D. Its association with other factors such as physical inactivity, involuntary weight loss, less muscle strength and slower gait can lead to frailty and limit the performance of basic daily activities. On the other hand, conventional training programs for resistance, aerobic or combined exercises are strongly recommended for people with T2D, as they promote a reduction in the glycemic rate and blood pressure, and an improvement in functional capacity. Unconventional training programs such as PILATES (dynamic and isometric muscle actions) ensure the control of forces that act on the musculoskeletal system, promoting an important improvement in functional capacity and possible cardiovascular adaptations. Additionally, elderly people have pronounced losses of neuromuscular adaptations even in a short period of detraining, compromising gains related to functional capacity and this loss can be even more pronounced in patients with T2D. Therefore, it is also necessary for training professionals to understand the effects of the short detraining period after unconventional exercise programs like PILATES on the functional capacity of elderly women with T2D as well as to understand the effects of the PILATES training on blood pressure or cardiovascular adaptations.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 19, 2016
Est. primary completion date November 28, 2016
Accepts healthy volunteers No
Gender Female
Age group 60 Years and older
Eligibility Inclusion Criteria: - Present a diagnosis of type-2 diabetes; - Do not have severe or decompensated heart disease; - Do not have coronary artery disease; - Do not have peripheral neuropathy and ulcers in the extremities; - Do not have severe skin lesions; - Do not have proliferative retinopathy; - Do not have insulin therapy; - Do not have any health condition that would hinder participation in the exercise sessions. Exclusion Criteria: - Present some unexpected abnormality in health conditions during the research; - Do not participate in more than 80% of the training sessions in the PILATES group.

Study Design


Intervention

Other:
PILATES Training
During the PILATES sessions, the practitioner received orientations to to perform slow movements, aware, and combined with the respiratory cycle. The exercises program was performed on a soft ground covered with tatamis. During the program, a set of swiss balls of 45, 55, and 65 cm in size and elastic bands of very moderate resistance were used. Each exercise session was divided into 3 stages, namely (a) global initial static and dynamic stretching (10 minutes); (b) general conditioning (45 minutes) and; (c) relaxation (5 minutes). The amount of series and repetitions per set in exercises, in addition to the intensity required in each session in PILATES is presented in Table 2 of Melo et al. (2020) - Vide reference.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do vale do São Francisco

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Change in functional capacity in type-2 diabetes Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments. Pre-intervention (week zero) versus 4 weeks of intervention in PILATES Group and CONTROL group
Primary Change in functional capacity in type-2 diabetes Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments. Pre-intervention (week zero) versus 8 weeks of intervention in PILATES Group and CONTROL group
Primary Change in functional capacity in type-2 diabetes Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments. Pre-intervention (week zero) versus 12 weeks post-intervention in PILATES Group and CONTROL group
Primary Change in functional capacity in type-2 diabetes Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and detraining moments. Pre-intervention (week zero) versus 4 weeks of detraining post-intervention in PILATES Group and CONTROL group
Primary Change in functional capacity in type-2 diabetes Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the post-intervention and detraining moments. Pos-intervention (12 weeks) versus 4 weeks of detraining (4W_DT) in PILATES Group and CONTROL group
Primary Change in blood pressure in type-2 diabetes Measurements of systolic blood pressure and diastolic blood pressure (mmHg) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments. Pre-intervention (week zero) versus 4 weeks of intervention in PILATES Group and CONTROL group
Primary Change in lood pressure in type-2 diabetes Measurements of systolic blood pressure and diastolic blood pressure (mmHg) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments. Pre-intervention (week zero) versus 8 weeks of intervention in PILATES Group and CONTROL group
Primary Change in blood pressure in type-2 diabetes Measurements of systolic blood pressure and diastolic blood pressure (mmHg) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments. Pre-intervention (week zero) versus 12 weeks post-intervention in PILATES Group and CONTROL group
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