- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04952948
Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes
2 juillet 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
22
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur factice: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in functional capacity in type-2 diabetes
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chaise d'étude: Ilka Yolane TP Andrade, Ms, Federal University of Vale do São Francisco - UNIVASF
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
23 août 2016
Achèvement primaire (Réel)
28 novembre 2016
Achèvement de l'étude (Réel)
19 décembre 2016
Dates d'inscription aux études
Première soumission
11 juin 2021
Première soumission répondant aux critères de contrôle qualité
2 juillet 2021
Première publication (Réel)
7 juillet 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juillet 2021
Dernière vérification
1 juillet 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .