Clinical trial NCT04952948: Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes
Official title: Effect of Short Period of Detraining of the Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type-2 Diabetes
Physical Disability
Blood Pressure
Keywords: Resistance exercise
Functionality
Interruption
Diabetes
Cardiovascular
Lead sponsor: Universidade Federal do vale do São Francisco
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 22
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in functional capacity in type-2 diabetes
timeFrame: Pre-intervention (week zero) versus 4 weeks of intervention in PILATES Group and CONTROL group
measure: Change in functional capacity in type-2 diabetes
timeFrame: Pre-intervention (week zero) versus 8 weeks of intervention in PILATES Group and CONTROL group
measure: Change in functional capacity in type-2 diabetes
timeFrame: Pre-intervention (week zero) versus 12 weeks post-intervention in PILATES Group and CONTROL group
measure: Change in functional capacity in type-2 diabetes
timeFrame: Pre-intervention (week zero) versus 4 weeks of detraining post-intervention in PILATES Group and CONTROL group
measure: Change in functional capacity in type-2 diabetes
timeFrame: Pos-intervention (12 weeks) versus 4 weeks of detraining (4W_DT) in PILATES Group and CONTROL group
measure: Change in blood pressure in type-2 diabetes
timeFrame: Pre-intervention (week zero) versus 4 weeks of intervention in PILATES Group and CONTROL group
measure: Change in lood pressure in type-2 diabetes
timeFrame: Pre-intervention (week zero) versus 8 weeks of intervention in PILATES Group and CONTROL group
measure: Change in blood pressure in type-2 diabetes
timeFrame: Pre-intervention (week zero) versus 12 weeks post-intervention in PILATES Group and CONTROL group
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Vale do São Francisco - UNIVASF
name: Ilka Yolane TP Andrade, Ms
role: STUDY_CHAIR
References:
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.