Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes (The PRACTICE Trial)

Hospital de Clinicas de Porto Alegre

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Control group; Other: Physical activity promotion

Study type: Interventional

Funder types: Other

Identifiers

NCT05347862

20210394

Details and patient eligibility

About

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 counseling, in glycemic levels, level of physical activity and quality of life in adults in elderly with T2D.

Full 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 people with T2DM.

The duration of the trial will be 24 weeks. Participants will be allocated to the intervention group or control group. The data collection will include variables related to (a) physical activity levels; (b) quality of life; (c) self-care in T2D; (d) functional capacity levels; and (e) adverse events related or not to the study.

Enrollment: 344 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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344 participants in 2 patient groups

Control group

Other group

Description:

Usual standard advice to practice physical activity as an important measure to promote health benefits.

Treatment:

Other: Control group

Physical Activity Promotion

Experimental group

Description:

The intervention will consist of telephone calls and text messages to promote the practice of 150 minutes/week of physical activity in the daily life of participants.

Treatment:

Other: Physical activity promotion