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| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | Usual standard advice to practice physical activity as an important measure to promote health benefits. |
|
| Physical Activity Promotion | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Sitting time |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Walking capacity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Umpierre, PhD | Contact | 555133596332 | danielumpierre@hcpa.edu.br | |
| Jayne Santos Leite, Master | Contact | 555133596332 | jsleite@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Umpierre, PhD | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-007 | Brazil |
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| Label | URL |
|---|---|
| Study repository - Open Science Framework | View source |
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Individual participant data after will be shared after trial completion. Data usage will be under the PI's auspices, but restrictions or screenings will not be imposed upon data requests. Outcomes data and any deemed relevant support information (sociodemographic, clinical history and allocated groups) will be shared if available.
Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol (links to be added as soon as available).
Data on other outcomes could be requested contacting the PI. Data access will be available after all participants completed the study and will remain accessible for as long as deemed necessary by the study's committee. Data sets, variables' dictionary and statistical analysis description will be made available online upon registration and acceptance of the study team's data sharing terms and policy.
The individual participant dataset will become available in a public repository up to six months after the first study publication.
A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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.
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Single-blind masking
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| Physical activity promotion | Other | 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. |
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The sitting time will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).
| Baseline; 12 weeks; 24 weeks. |
| Medication changes | Participants' reports of medication changes (increases, decreases, or no changes in medication treatment) during the intervention period. | Monthly, up to 24 weeks. |
| 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. |
Total distance (in meters) performed during the six-minute walk test.
| Baseline; 12 weeks; 24 weeks. |
| Handgrip strength | Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer. | Baseline; 12 weeks; 24 weeks. |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D008722 | Methods |