Clinical trial NCT05347862: Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes (The PRACTICE Trial)
Official title: Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes: a Pragmatic Clinical Trial - The PRACTICE Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes mellitus
randomized controlled trial
physical activity
aging
pragmatic clinical trial
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2022-04-26
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pragmatic trial to assess the effectiveness of a physical activity promotion program on reduction levels of glycated hemoglobin in patients with Type 2 diabetes.
Primary purpose: TREATMENT

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

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from Baseline Glycated Hemoglobin at 3 and 6 months
timeFrame: Baseline; 12 weeks; 24 weeks.
Secondary outcomes:
measure: Physical Activity Levels
timeFrame: Baseline; 12 weeks; 24 weeks.
measure: Sitting time
timeFrame: Baseline; 12 weeks; 24 weeks.
measure: Medication changes
timeFrame: Monthly, up to 24 weeks.
measure: Short Form Health Survey (SF-36)
timeFrame: Baseline; 12 weeks; 24 weeks.
Other outcomes:
measure: Blood pressure
timeFrame: Baseline; 12 weeks; 24 weeks.
measure: Walking capacity
timeFrame: Baseline; 12 weeks; 24 weeks.
measure: Handgrip strength
timeFrame: Baseline; 12 weeks; 24 weeks.
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Daniel Umpierre, PhD
role: PRINCIPAL_INVESTIGATOR
References: