Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
Assessment of Feasibility and Efficacy of a Project Aimed to Improve Metabolic Control in Type 2 Diabetes Through Lifestyle Changes and Self-monitoring of Blood Glucose
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with type 2 diabetes. In addition, these programmes may favourably affect several other cardiovascular risk factors in these subjects. However, it still remains unclear how this evidence can be transferred into clinical practice, considering the very large number of diabetic patients and the characteristics of this population, made up predominantly of elderly, sedentary and overweight patients. In this regard, a realistic approach to this issue requires simple and easily available intervention models.
Walking is a typical mild-moderate aerobic physical activity which is easy to organize and does not require specific skills or preliminary sophisticated medical evaluations. This activity could therefore fit well with the need of involvement of large numbers of patients in different logistic situations. However, it has been reported that, due to the low walking speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a significant metabolic improvement in these subjects.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- diabetes known for at least 2 yr
- physical inactivity
- haemoglobin (Hb)A1c between 6.5-9.9%
- treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection
- willingness to participate in a programme of regular physical activity
Exclusion Criteria:
- moderate-severe autonomic or somatic neuropathy
- severe lower limb vasculopathy
- pre-proliferative or proliferative active retinopathy
- moderate to severe chronic renal failure
- unstable angina or recent (in the previous 3 months) myocardial infarction
- acute intercurrent diseases
- acute metabolic decompensation (blood glucose >300 mg/dl or ketonuria in two consecutive checks)
- use of beta-blocker drugs
- subjects unable to complete a 6-min walk test
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Supervised walking groups
Patients included in walking groups, under the supervision of a qualified personal trainer.
|
Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.
|
|
Comparateur actif: Controls
Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.
|
Verbal and written information about the benefits of exercise and instructions aimed to encourage physical activity.
In addition, one group session of counselling on these issues.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in haemoglobin A1c (HbA1c) levels
Délai: 4 months
|
The measurement of HbA1c is carried out with a DCCT-aligned method.
|
4 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Body weight
Délai: 4 months
|
4 months
|
|
|
Change in Fasting plasma glucose levels
Délai: 4 months
|
4 months
|
|
|
Change in Total Cholesterol levels
Délai: 4 months
|
4 months
|
|
|
Change in HDL Cholesterol levels
Délai: 4 months
|
4 months
|
|
|
Change in LDL Cholesterol levels
Délai: 4 months
|
4 months
|
|
|
Change in Triglycerides levels
Délai: 4 months
|
4 months
|
|
|
Change in Blood Pressure
Délai: 4 months
|
4 months
|
|
|
Changement en 6 minutes à pied
Délai: 4 mois
|
Ce test mesure le nombre de mètres qu'il est possible de parcourir en 6 minutes sur un parcours de 30 m.
Il s'agit d'un simple test sur le terrain pour évaluer la capacité fonctionnelle aérobie.
|
4 mois
|
|
Change in C-reactive protein levels
Délai: 4 months
|
4 months
|
|
|
Change in Energy expenditure through voluntary physical activity
Délai: 4 months
|
Energy expenditure is estimated through 7-day activity diaries.
The intensity of each activity (defined in metabolic equivalents, MET) is multiplied by duration and the product for each activity is summed to give a total activity score in MET hours/week.
|
4 months
|
|
Change in Antidiabetic medications
Délai: 4 months
|
Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol, to assess changes in hypoglycemic medication during the trial.
|
4 months
|
|
Compliance with walking sessions
Délai: 4 months
|
Attendance at the scheduled walking sessions is recorded for each patient.
|
4 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Paolo Moghetti, M.D., Ph.D., Universita di Verona
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CE 1264
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