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Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes

2 lipca 2021 zaktualizowane przez: Sérgio Rodrigues Moreira, Universidade Federal do vale do São Francisco

Effect of Short Period of Detraining of the Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes

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.

Przegląd badań

Status

Zakończony

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

22

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

60 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: PILATES Method Training Group
The PILATES program at moderate intensity lasted 12 weeks, at a frequency of 3 times a week, and with duration of 60 minutes for each exercise session.
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.
Pozorny komparator: CONTROL Group
While the PILATES Group participated in the intervention with physical exercises, the CONTROL group only participated in the functional capacity and blood pressure assessments. However, at the end of the intervention in the PILATES Group, the CONTROL Group was invited to participate in a similar training program.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in functional capacity in type-2 diabetes
Ramy czasowe: Pre-intervention (week zero) versus 4 weeks of intervention in PILATES Group and CONTROL group
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
Change in functional capacity in type-2 diabetes
Ramy czasowe: Pre-intervention (week zero) versus 8 weeks of intervention in PILATES Group and CONTROL group
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
Change in functional capacity in type-2 diabetes
Ramy czasowe: Pre-intervention (week zero) versus 12 weeks post-intervention in PILATES Group and CONTROL group
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
Change in functional capacity in type-2 diabetes
Ramy czasowe: Pre-intervention (week zero) versus 4 weeks of detraining post-intervention in PILATES Group and CONTROL group
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
Change in functional capacity in type-2 diabetes
Ramy czasowe: Pos-intervention (12 weeks) versus 4 weeks of detraining (4W_DT) in PILATES Group and CONTROL group
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
Change in blood pressure in type-2 diabetes
Ramy czasowe: Pre-intervention (week zero) versus 4 weeks of intervention in PILATES Group and CONTROL group
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
Change in lood pressure in type-2 diabetes
Ramy czasowe: Pre-intervention (week zero) versus 8 weeks of intervention in PILATES Group and CONTROL group
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
Change in blood pressure in type-2 diabetes
Ramy czasowe: Pre-intervention (week zero) versus 12 weeks post-intervention in PILATES Group and CONTROL group
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Krzesło do nauki: Ilka Yolane TP Andrade, Ms, Federal University of Vale do São Francisco - UNIVASF

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 sierpnia 2016

Zakończenie podstawowe (Rzeczywisty)

28 listopada 2016

Ukończenie studiów (Rzeczywisty)

19 grudnia 2016

Daty rejestracji na studia

Pierwszy przesłany

11 czerwca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lipca 2021

Pierwszy wysłany (Rzeczywisty)

7 lipca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 lipca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2021

Ostatnia weryfikacja

1 lipca 2021

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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