- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04952948
Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes
perjantai 2. heinäkuuta 2021 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
22
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
60 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Nainen
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Huijausvertailija: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in functional capacity in type-2 diabetes
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Opintojen puheenjohtaja: Ilka Yolane TP Andrade, Ms, Federal University of Vale do São Francisco - UNIVASF
Julkaisuja ja hyödyllisiä linkkejä
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Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Tiistai 23. elokuuta 2016
Ensisijainen valmistuminen (Todellinen)
Maanantai 28. marraskuuta 2016
Opintojen valmistuminen (Todellinen)
Maanantai 19. joulukuuta 2016
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 11. kesäkuuta 2021
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 2. heinäkuuta 2021
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 7. heinäkuuta 2021
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 7. heinäkuuta 2021
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 2. heinäkuuta 2021
Viimeksi vahvistettu
Torstai 1. heinäkuuta 2021
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