- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04952948
Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes
2. juli 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
22
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Sham-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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in functional capacity in type-2 diabetes
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Ilka Yolane TP Andrade, Ms, Federal University of Vale do São Francisco - UNIVASF
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. august 2016
Primær fullføring (Faktiske)
28. november 2016
Studiet fullført (Faktiske)
19. desember 2016
Datoer for studieregistrering
Først innsendt
11. juni 2021
Først innsendt som oppfylte QC-kriteriene
2. juli 2021
Først lagt ut (Faktiske)
7. juli 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juli 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2021
Sist bekreftet
1. juli 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Blodtrykk
-
John M. StulakFullført
-
Assiut UniversityHar ikke rekruttert ennåGyldighet av Blood Pool SUV-ratio i identifisering av malignitet i tilfelle av syk lever
-
Academisch Medisch Centrum - Universiteit van Amsterdam...European Regional Development Fund; HaermonicsAvsluttetPostoperativ blødning | Hjertetamponade | Hjertekirurgiske prosedyrer | Retained Blood SyndromeNederland
-
Bactiguard ABKarolinska University HospitalFullførtKirurgi | Central Line Associated Blood Stream Infections (CLABSI)Sverige
-
Guang'anmen Hospital of China Academy of Chinese...UkjentKoronar hjertesykdom | Ustabil angina | Blood Stasis SyndromeKina
Kliniske studier på PILATES Training
-
Florida State UniversityRekruttering
-
Florida State UniversityNational Institute of Mental Health (NIMH); National Institutes of Health...Fullført
-
University of MagdeburgFullførtHjerneskader, traumatiske | HemianopiTyskland
-
University of KentuckyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbeidspartnereRekrutteringDiabetes mellitus, type 2Forente stater
-
Stony Brook UniversityNorthwell Health; Department of Health and Human Services; Rutgers UniversityFullført
-
University College, LondonFullført
-
Tufts UniversityFullført
-
Copka SonpashanHar ikke rekruttert ennå
-
Dana-Farber Cancer InstituteProstate Cancer FoundationRekrutteringPROSTATAKREFT | Metastatisk prostatakreft | Metastatisk prostatakarsinomForente stater
-
Uşak UniversityFullførtLivskvalitet | Overholdelse av behandlingTyrkia