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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in haemoglobin A1c (HbA1c) levels
Tidsramme: 4 months
|
The measurement of HbA1c is carried out with a DCCT-aligned method.
|
4 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body weight
Tidsramme: 4 months
|
4 months
|
|
|
Change in Fasting plasma glucose levels
Tidsramme: 4 months
|
4 months
|
|
|
Change in Total Cholesterol levels
Tidsramme: 4 months
|
4 months
|
|
|
Change in HDL Cholesterol levels
Tidsramme: 4 months
|
4 months
|
|
|
Change in LDL Cholesterol levels
Tidsramme: 4 months
|
4 months
|
|
|
Change in Triglycerides levels
Tidsramme: 4 months
|
4 months
|
|
|
Change in Blood Pressure
Tidsramme: 4 months
|
4 months
|
|
|
Bytt på 6 minutters gangavstand
Tidsramme: 4 måneder
|
Denne testen måler antall meter som kan gås på 6 minutter over en 30 m bane.
Det er en enkel felttest for å vurdere aerob funksjonsevne.
|
4 måneder
|
|
Change in C-reactive protein levels
Tidsramme: 4 months
|
4 months
|
|
|
Change in Energy expenditure through voluntary physical activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 4 months
|
Attendance at the scheduled walking sessions is recorded for each patient.
|
4 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Paolo Moghetti, M.D., Ph.D., Universita di Verona
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CE 1264
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