Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Web-based Exercise for South Asian People With Type 2 Diabetes

20 novembre 2018 mis à jour par: NHS Greater Glasgow and Clyde

Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial

This randomised controlled trial aims to investigate the effect of a 12 week personalised exercise programme delivered using a web-based platform, compared to usual care, on glycaemic control, muscle strength, functional ability, blood lipid profile, blood pressure and quality of life in adult South Asians with Type 2 Diabetes Mellitus

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

A mixed method approach involving both qualitative and quantitative methods will be used.

The quantitative component will consist of a single blind, randomised controlled trial (RCT), which will explore the effects of the intervention on glycaemic control (blood sugar levels) and other secondary outcomes.

The qualitative component will consist of face to face interviews to explore the views of participants regarding acceptability and barriers affecting adherence to this intervention.

Potential participants will be informed about the study at hospital diabetes clinics, community health organisations, support groups, places of worship and General Practitioner (GP) surgeries. Recruitment is estimated to last for 9 months. Potential participants will be sent a participant information sheet (PIS) in either English or Urdu, depending on their preference. Those wishing to take part will meet the researcher at a convenient location, for eligibility screening and consent. If necessary, translation services can be arranged for those with limited English throughout the study.

Following baseline assessment, participants will be randomised to either the intervention or control group. Participants in the control group will be asked to continue their usual care and day to day physical activity routine. In addition, they will be given general information about diabetes management. Participants who wish to use the website for exercise will be provided with access at the end of all assessments.

Participants assigned to the intervention group will be asked to perform a personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks. Participants will meet the researcher face to face immediately after randomisation. During this meeting, a brief physical assessment will be undertaken and exercise goals will be discussed and agreed with participants. The researcher will then design a personalised exercise programme for each participant using the resources available on the web-based exercise website. The exercise programme prescription and progression will be in line with American Diabetes Association (ADA) and American College of Sports Medicine (ACSM) guidelines (Colberg et al. 2016). The website (www.webbasedphysio.com) will be used to deliver the intervention. This website has been modified, in collaboration with South Asians, to be culturally suitable for people of South Asian backgrounds in terms of content and language (Albalawi et al, under review). The researcher will contact participants every two weeks via telephone to encourage use of the website, ask about progress, and to deal with any technical issues that they might face while using the website. Participants will be advised to contact the researcher to request a change in their programme or if a problem arises. The researcher will make changes remotely and participants will be informed of any changes by phone or email. Participants will be asked to meet the researcher face to face to discuss progression and goals at week 6 (midway). Regardless of groups allocation, all participants will be assessed three times by a blind assessor at baseline (week=0) , after the end of the intervention (week=12) and 8 weeks after the end of the intervention (week=20).

Assessment of outcome measures will take place at convenient locations and each visit should take no more than 90 minutes. Travel expenses will be provided.

All participants will be informed that they are free to withdraw from the study at any time without being obliged to give notice or provide any explanation. Any data collected before their withdrawal will be considered in the analysis.

Type d'étude

Interventionnel

Inscription (Réel)

33

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Royaume-Uni
      • Glasgow, Royaume-Uni
        • NHS Greater Glasgow and Clyde

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

25 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • define themselves as South Asians
  • BMI 21 - 29.9 kg/m2
  • diagnosed with Type 2 Diabetes Mellitus (T2DM) by a physician more than 6 months previously
  • access to a personal computer/tablet, smart phone or smart television with an email address and Internet connection
  • able to understand English or Urdu

Exclusion Criteria:

  • type 1 diabetes
  • any medical conditions that would affect adherence or contraindicate exercise including severe peripheral neuropathy, severe autonomic neuropathy, severe physical limitations, heart disease, pre-proliferative or proliferative retinopathy, uncontrolled hypertension (>180/ 100mmHg), or coronary artery disease.
  • people using insulin if they do not have a self-monitoring glucose device or are unable to use such devices.
  • engaging in exercise training of 150 minutes a week or more
  • participating in other interventional studies aiming to improve glycaemic control
  • unwilling to be randomised

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: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Groupe de contrôle
Soins habituels
Expérimental: Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
Comportemental: Web-based exercise programme
Aerobic, resistance and balance exercises

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Glycaemic control
Délai: Baseline to 12 weeks
Change in HbA1c
Baseline to 12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Blood lipid profile (cholesterol)
Délai: Baseline to 12 weeks
Change in total cholesterol level
Baseline to 12 weeks
Blood lipid profile (cholesterol)
Délai: 12 weeks to 20 weeks
Change in total cholesterol level
12 weeks to 20 weeks
Blood lipid profile (high density lipoproteins)
Délai: Baseline to 12 weeks
Change in high density lipoprotein (HDL) level
Baseline to 12 weeks
Blood lipid profile (high density lipoproteins)
Délai: 12 weeks to 20 weeks
Change in high density lipoprotein (HDL) level
12 weeks to 20 weeks
Blood lipid profile (low-density lipoproteins)
Délai: Baseline to 12 weeks
Change in low density lipoprotein (LDL) level
Baseline to 12 weeks
Blood lipid profile (low-density lipoproteins)
Délai: 12 weeks to 20 weeks
Change in low density lipoprotein (LDL) level
12 weeks to 20 weeks
Blood lipid profile (triglyceride)
Délai: Baseline to 12 weeks
Change in triglyceride level
Baseline to 12 weeks
Blood lipid profile (triglyceride)
Délai: 12 weeks to 20 weeks
Change in triglyceride level
12 weeks to 20 weeks
Blood pressure
Délai: Baseline to 12 weeks
Change in blood pressure result
Baseline to 12 weeks
Blood pressure
Délai: 12 weeks to 20 weeks
Change in blood pressure result
12 weeks to 20 weeks
Body mass index (BMI)
Délai: Baseline to 12 weeks
Change in BMI
Baseline to 12 weeks
Body mass index (BMI)
Délai: 12 weeks to 20 weeks
Change in BMI
12 weeks to 20 weeks
Waist circumference
Délai: Baseline to 12 weeks
Change in waist circumference
Baseline to 12 weeks
Waist circumference
Délai: 12 weeks to 20 weeks
Change in waist circumference
12 weeks to 20 weeks
Ten metre walking test (10MWT)
Délai: Baseline to 12 weeks
Change in 10 MWT result
Baseline to 12 weeks
Ten metre walking test (10MWT)
Délai: 12 weeks to 20 weeks
Change in 10 MWT result
12 weeks to 20 weeks
Timed Up and Go test
Délai: Baseline to 12 weeks
Change in Timed Up and Go test result
Baseline to 12 weeks
Timed Up and Go test
Délai: 12 weeks to 20 weeks
Change in Timed Up and Go test result
12 weeks to 20 weeks
Muscle power
Délai: Baseline to 12 weeks
Change in hand grip dynamometer score
Baseline to 12 weeks
Muscle power
Délai: 12 weeks to 20 weeks
Change in hand grip dynamometer score
12 weeks to 20 weeks
Quality of Life - WHO-QOL BREF score
Délai: Baseline to 12 weeks
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
Baseline to 12 weeks
Quality of Life - WHO-QOL BREF score
Délai: 12 weeks to 20 weeks
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
12 weeks to 20 weeks
Adherence - exercise diary completion
Délai: 12 weeks
Number of times exercise diary completed
12 weeks
Dietary intake
Délai: Baseline to 12 weeks
Change in Food Frequency Questionnaire score
Baseline to 12 weeks
Dietary intake
Délai: 12 weeks to 20 weeks
Change in Food Frequency Questionnaire score
12 weeks to 20 weeks
Change in Medication
Délai: Baseline to 12 weeks
Change in medication
Baseline to 12 weeks
Change in Medication
Délai: 12 weeks to 20 weeks
Change in medication
12 weeks to 20 weeks
Glycaemic control
Délai: 12 weeks to 20 weeks
Change in HbA1c
12 weeks to 20 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

NHS Greater Glasgow and Clyde

Collaborateurs

University of Glasgow

Les enquêteurs

  • Directeur d'études: Lorna Paul, PhD, Glasgow Caledonian University

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)

6 novembre 2017

Achèvement primaire (Réel)

22 août 2018

Achèvement de l'étude (Réel)

22 août 2018

Dates d'inscription aux études

Première soumission

27 juin 2017

Première soumission répondant aux critères de contrôle qualité

27 juin 2017

Première publication (Réel)

29 juin 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 novembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 novembre 2018

Dernière vérification

1 novembre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GN17DI329

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 .

Essais cliniques sur Diabète sucré, Type 2

Essais cliniques sur Web-based exercise programme

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Azerbaijan

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

S'abonner