Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes mellitus, randomized controlled trial, physical activity, aging, pragmatic clinical trial
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.
Interventions
OTHERControl 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.
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.
Sponsors
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-blind masking
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Sitting time | Baseline; 12 weeks; 24 weeks. | The sitting time will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version). |
| 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). |
| Medication changes | Monthly, up to 24 weeks. | Participants' reports of medication changes (increases, decreases, or no changes in medication treatment) during the intervention period. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | Baseline; 12 weeks; 24 weeks. | Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer. |
| Walking capacity | Baseline; 12 weeks; 24 weeks. | Total distance (in meters) performed during the six-minute walk test. |
| Blood pressure | Baseline; 12 weeks; 24 weeks. | This outcome will be assessed by measuring systolic and diastolic blood pressure in accordance to clinical guidelines and using an automated oscillometric device. |
Countries
Brazil
Contacts
Primary ContactDaniel Umpierre, PhD
Backup ContactJayne Santos Leite, Master
Outcome results
None listed