- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04952948
Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes
2. července 2021 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Intervenční
Zápis (Aktuální)
22
Fáze
- Nelze použít
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
60 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Falešný srovnávač: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in functional capacity in type-2 diabetes
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Studijní židle: Ilka Yolane TP Andrade, Ms, Federal University of Vale do São Francisco - UNIVASF
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
23. srpna 2016
Primární dokončení (Aktuální)
28. listopadu 2016
Dokončení studie (Aktuální)
19. prosince 2016
Termíny zápisu do studia
První předloženo
11. června 2021
První předloženo, které splnilo kritéria kontroly kvality
2. července 2021
První zveřejněno (Aktuální)
7. července 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. července 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. července 2021
Naposledy ověřeno
1. července 2021
Více informací
Termíny související s touto studií
Klíčová slova
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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