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

Type 2 Diabetes Clinical Trial

— PRACTICE  

Official title:

Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes: a Pragmatic Clinical Trial - The PRACTICE Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05347862
• Other study ID #: 20210394
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Daniel Umpierre, PhD
• Phone: 555133596332
• Email: danielumpierre[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 344
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Control group
At baseline, this group will receive only the usual standard advice to practice physical activity as an important measure to promote health benefits. During the intervention period, they will receive only telephone calls monthly to assess the physical activity practice, changes in medication, and adverse events. When appropriate, evaluations of 12 and 24 weeks will be scheduled.
• Physical activity promotion
The intervention will be based on a remote approach, for 24 weeks. The intervention will consist of telephone calls and sent messages to promote the practice of 150 minutes/week of physical activity in the daily life of participants, plus short text messages promoting health behaviors related to self-care, nutrition, physical activity, and sedentary behavior. Initially, this group will be followed weekly during the first 4 weeks. After this period this group can up to two weekly calls, according to their preference. The text messages will be weekly. During the telephone calls, the research team will verify the volume of PA achieved and help the participants to identify and overcome barriers to PA practice, and motivate and register any adverse events related or not to the study.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure	This outcome will be assessed by measuring systolic and diastolic blood pressure in accordance to clinical guidelines and using an automated oscillometric device.	Baseline; 12 weeks; 24 weeks.
Other	Walking capacity	Total distance (in meters) performed during the six-minute walk test.	Baseline; 12 weeks; 24 weeks.
Other	Handgrip strength	Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.	Baseline; 12 weeks; 24 weeks.
Primary	Change from Baseline Glycated Hemoglobin at 3 and 6 months	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.	Baseline; 12 weeks; 24 weeks.
Secondary	Physical Activity Levels	The levels of physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).	Baseline; 12 weeks; 24 weeks.
Secondary	Sitting time	The sitting time will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).	Baseline; 12 weeks; 24 weeks.
Secondary	Medication changes	Participants' reports of medication changes (increases, decreases, or no changes in medication treatment) during the intervention period.	Monthly, up to 24 weeks.
Secondary	Short Form Health Survey (SF-36)	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.	Baseline; 12 weeks; 24 weeks.

External Links

•   Study repository - Open Science Framework