- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04952948
Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes
2. Juli 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
22
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
60 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Schein-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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in functional capacity in type-2 diabetes
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienstuhl: Ilka Yolane TP Andrade, Ms, Federal University of Vale do São Francisco - UNIVASF
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
23. August 2016
Primärer Abschluss (Tatsächlich)
28. November 2016
Studienabschluss (Tatsächlich)
19. Dezember 2016
Studienanmeldedaten
Zuerst eingereicht
11. Juni 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Juli 2021
Zuerst gepostet (Tatsächlich)
7. Juli 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. Juli 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. Juli 2021
Zuletzt verifiziert
1. Juli 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 4
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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