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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Other: Physical activity promotion; Other: Control group

• Registration Number: NCT05347862
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Study Start: 2022-12-02
• Last Update Posted: 2022-12-02
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 344

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Promotion	Physical activity promotion	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.
Control group	Control group	Usual standard advice to practice physical activity as an important measure to promote health benefits.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Glycated Hemoglobin at 3 and 6 months	Baseline; 12 weeks; 24 weeks.	Glycated hemoglobin (HbA1c) is the primary outcome used for the comparison of a remote and intensive physical activity promotion program compared with usual advice for physical activity. The minimum clinically important difference considered for the study design and sample size calculation was an HbA1c reduction of 0.50% in favor of the remote and intensive physical activity promotion program.

Secondary Outcome Measures

Name	Time	Method
Medication changes	Monthly, up to 24 weeks.	Participants' reports of medication changes (increases, decreases, or no changes in medication treatment) during the intervention period.
Sitting time	Baseline; 12 weeks; 24 weeks.	The sitting time will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).
Short Form Health Survey (SF-36)	Baseline; 12 weeks; 24 weeks.	This instrument is a self-administered 36-item questionnaire. The score of quality of life ranges from 0 to 100, in which higher scores are indicative of better quality of life.
Physical Activity Levels	Baseline; 12 weeks; 24 weeks.	The levels of physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil