Status:
UNKNOWN
Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes (The PRACTICE Trial)
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this trial is to evaluate the effects of a remote and intensive physical activity promotion program for people with Type 2 Diabetes (T2D), in comparison to a usual model of PA counselin...
Detailed Description
The PRACTICE Trial aims to assess the effectiveness of a remote and intensive physical activity promotion program in contrast to the usual advice for physical activity on the management of HbA1c in pe...
Eligibility Criteria
Inclusion
- Eighteen years of age or older;
- Glycated hemoglobin ≥ 8.0%;
- Being a resident in Porto Alegre or metropolitan areas (Viamão, Alvorada, Cachoeirinha, or Canoas);
- Eligibility to perform physical activity after cardiovascular risk assessment;
- Have some means of access to the internet (direct access or via a family member who can receive the research material and share the information/material sent with the participant).
Exclusion
- Physically active, that is, performing at least 150 minutes of moderate to vigorous PA per week;
- Not having their own cell phone capable of receiving calls and text messages;
- Progressive neurological disorder (e.g., Parkinsonism, Alzheimer's Disease);
- Psychiatric disorder that makes the intervention unfeasible;
- Physical, language, hearing, vision or cognition disorder that makes it impossible to attend the evaluations and carry out the intervention;
- Severe cardiovascular disease (class III and IV heart failure, unstable angina), history of macrovascular event in the last 12 months (acute myocardial infarction, revascularization procedures, deep vein thrombosis, stroke or pulmonary embolism);
- Joint, muscle or bone injury that makes the intervention unfeasible;
- Planning to move to cities outside the geographic area where the study is carried out;
- Inadequate control of comorbidities. Resting systolic blood pressure \>180 mmHg and/or resting diastolic blood pressure \>100 mmHg;
- Physical limitation that makes it impossible or brings risk to the participant's practice (e.g. lower limb amputation that makes locomotion difficult, use of crutches, cane).
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT05347862
Start Date
December 2 2022
End Date
December 30 2025
Last Update
December 2 2022
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-007