Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes
Primary Purpose
Diabetes Mellitus, Prediabetes
Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise Program
Lifestyle Education Program
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Exercise, Health Education, Patient Education, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- Adult (> 18 years old);
- Clinical and laboratory diagnosis of Prediabetes or Diabetes Mellitus (type 1 or type 2);
- Clinical compensation (glycemic control);
- No cognitive limitation (score ≥ 4 in the six-item screener);
- No confirmed diagnosis of cardiovascular diseases such as unstable coronary artery disease (CAD), heart failure; use of a pacemaker and/or implantable cardioverter-defibrillator (ICD), intermittent claudication; no recent cardiovascular event or cardiac surgery (≤ 6 months);
- Participants not currently enrolled in a structured physical exercise program that follows diabetes guidelines.
Exclusion Criteria:
- Clinical decompensation that contraindicates the performance of physical exercises (not glycemic control);
- Physical and/or mental limitations that will prevent the participant to perform physical exercises and/or understanding of educational content;
- Complex ventricular arrhythmias (i.e., atrial flutter or atrial fibrillation, multiple atrial or ventricular ectopy, and atrioventricular or ventricular block.
Sites / Locations
- Federal University of Minas Gerais
- Hospital Universitário da UFJF
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Exercise Program
Exercise and Lifestyle Education Program
Arm Description
Ex: The participants will be submitted to only exercise sessions for 12 weeks.
ExLE: The participants will be submitted to exercise sessions and education classes for 12 weeks.
Outcomes
Primary Outcome Measures
Functional capacity
This outcome will be measured by the Incremental Shuttle Walk Test (ISWT) distance.
Disease-related knowledge
This outcome will be assessed from the total score of the Brazilian Portuguese version of the DiAbeTes Education Questionnaire (DATE-Q). This questionnaire is a 20-item self-administered tool (answer options are: true or false or do not know) equally distributed in five domains (self-management, long-term complications, being active, healthy eating, and psychosocial well-being) based on the Diabetes College. The total score ranges from 0 to 20, and higher scores indicate better disease-related knowledge.
Secondary Outcome Measures
Health Behavior: health literacy
This outcome will be measured by the Newest Vital Sign (NVS) tool score. This is a six-item toll regarding the information found on an accompanying nutrition label. Each correct response is worth one point with a total of six points possible. Scores equal or greater than four are evidence of adequate health literacy whereas scores below four are evidence of inadequate health literacy.
Health Behavior: physical activity level
This outcome will be measured from the total number of steps recorded by a pedometer during consecutive 7 days. For analysis of this outcome, the total number of steps recorded will be divided for seven in order to obtain the average number of steps/day for each participant. The level of physical activity will be classified from the average of steps/day, as follow: sedentary (<5000 steps/day); low active (5000-7499 steps/day); somewhat active (7500-9999 steps/day); active (≥10 000 steps/day) and highly active (>12 500 steps/day).
Health Behavior: exercise self-efficacy
This outcome will be assessed from the total score of the Brazilian Portuguese version of Bandura's exercise self-efficacy scale. This is an 18-item self-administered tool which item contents are related to situations that may compromise the adherence to regular physical exercising, e. g. when feeling tired or during the holidays. The respondent should indicate from 0 (no confident) to 100 (very confident) how much confidence he or she has about maintaining the physical exercise routine face of the situation described in that item. The total score is the average from the eighteen items scores, and higher total scores indicate great exercise self-efficacy.
Health Behavior: adherence to standard Mediterranean food elements
This outcome will be assessed from the total score of the Brazilian Portuguese version of the Mediterranean diet scale (MDS). The MDS has 13 items which quantitatively assess adherence to standard Mediterranean food elements [21]. The answer options are dichotomous: yes and no. Some questions have pictures and examples to help participants to answer the questions. One point is scored for each yes answered. Total scores range from 0 to 13. Scores below 5 indicate poor adherence to the MedDiet, and scores greater than 10 indicate high adherence.
Health Behavior: medication adherence
This outcome will be assessed from participants responses to a Likert Scale (scored from 1 (I do not or rarely use the prescribed medication) to 5 (I do always use the prescribed medication)) and by a five-item tool developed by the research team regarding the regular use of medicines with "yes" or "no" response options.
Cardiometabolic Health Parameter: glycemic control
This outcome will be assessed from the glycated hemoglobin (A1c) level obtained in routine tests dated no more than three months before the study assessment point.
Cardiometabolic Health Parameter: anthropometric characteristics
This outcome will be measured by the body mass index (BMI - kg/m2) and the waist circumference.
Cardiometabolic Health Parameter: cardiac autonomic control
This outcome will be assessed from heart rate variability (HRV) indexes.
Full Information
NCT ID
NCT03914924
First Posted
April 4, 2019
Last Updated
August 23, 2021
Sponsor
Federal University of Juiz de Fora
Collaborators
Federal University of Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT03914924
Brief Title
Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes
Official Title
Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes: A Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Juiz de Fora
Collaborators
Federal University of Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to pragmatically investigate whether participation of people with diabetes and prediabetes in an Exercise and Lifestyle Education Program (i.e., exercise and education classes) results in better functional capacity, disease-related knowledge and behavior, and cardiometabolic health parameters when compared to Exercise Program (i.e., exercise class only). In addition, the effects of these interventions will be evaluated on other outcomes: program adherence, satisfaction with the program, quality of life, diet quality, depression, and morbidity associated with diabetes in the 6 months follow-up.
Detailed Description
The design is a multicenter, double-blind (outcomes assessors and data analysts), randomized and controlled trial with 2 parallel arms: Exercise Program (Ex) and Exercise and Lifestyle Education Program (ExLE). The sample size was calculated considering the ISWT distance as the primary outcome and based on a previous study that tested the effects of a comprehensive cardiac rehabilitation program on the same primary outcome in coronary patients. The calculation was made using R Software version 3.4.3 and considering the following parameters: moderate effect size (d = 0.20), the statistical power of 80%, an alpha level of 5%, one-sided test, two arms, and three measurements. A total of 200 participants (100 per program) was required. Assuming a 20% attrition rate based on previous studies using educational intervention in Cardiac Rehabilitation patients, it will take 120 participants in each program to sign the consent form to have 200 participants complete the study.
Adults with diabetes and prediabetes will be recruited from the public and private health services in two Brazilian cities (Belo Horizonte and Juiz de Fora). Volunteers will participate in the interventions for 12 weeks and be invited for follow-up and reassessment after 6 months of program completion. In this sense, three assessments will be performed: pre-intervention (baseline), after 12 weeks of intervention, and 6 months post-program completion.
The initial assessment will comprise an interview to obtain their clinical characteristics and sociodemographic data, medical history, vital signs measurement, electrocardiographic monitoring, and measurement of primary, secondary and tertiary outcomes (other pre-specified outcome measures) through questionnaires and specific tests.
The number of patients approached, the date and the reasons for inclusion/exclusion will be registered. With informed written consent from the patient, potentially eligible participants will be scheduled to come on-site to complete initial assessments. Eligible participants will be randomized to one of the 2 groups. The generation of the randomized allocation sequence will be performed by the project coordinator using the software available on the website www.randomization.com. To ensure allocation concealment, the local research coordinators have the allocation sequence in a password-protected file. They will only provide randomization information to the research team member once it is confirmed the participant is eligible. Due to the nature of the intervention, participants and the research team members cannot be blind to the treatment allocated. However, an independent research member blinded to the group allocation will perform database management and analyses.
The group Ex and ExLE participants will be submitted to a supervised and individually prescribed exercise program consisting of aerobic (walking) and muscle-strengthening exercise sessions. This exercise program is 12 weeks in duration with 16 exercise sessions of approximately 1 hour offered at the following frequencies:
Stage 1: 4 weeks - supervised exercise sessions 2x/week
Stage 2: 8 weeks - supervised exercise sessions 1x/week
Each session will be constituted by moderate-intensity walking and muscle strength exercises encompassing the main muscle groups, using bodyweight or elastic bands.
In addition, they will receive counseling for unsupervised exercise sessions in their community to aim to accumulate a minimum of 150 min/week.
Participants in ExLE also attend education classes using the educational curriculum of Diabetes College offered through different tools, including the website, patient workbook, and learning management. A health educator team will deliver education classes after each exercise session, and participants receive a comprehensive education workbook to accompany the sessions.
The workbook was developed by Diabetes College group researchers in Canada, and the English version has been translated and culturally adapted to Brazilian Portuguese. This tool, titled "A Guide to Help You Live and Thrive with Diabetes" or "Guia para Uma Vida Plena com Diabetes," contains 20 chapters developed by a multi-disciplinary committee of health professionals based on diabetes patients' needs. Chapters are organized into 5 sections: treat diabetes, get active, eat healthy, feel well, and take control. In total, there will be offered 18 educational sessions since there will be an initial extra class for program introduction and an extra final class for program graduation.
Diabetes College is an educational program that helps people live and thrive with diabetes. The program development was based on patients' educational needs (assessed by the information needs assessment and focus groups) in the University Health Network in Toronto/Canada. This program can help diabetes patients improve their health and functional capacity, make lifestyle changes, control their blood sugar, and prevent diabetes (if they have prediabetes). These objectives can be achieved by teaching patients what diabetes is and how it impacts their health, how diabetes medicines work and help control blood sugar, and how to make lifestyle changes to take control of their health.
All participants will be invited to the follow-up after completion of the interventions.
During the 6-month follow-up, participants will be instructed to record their Diabetes-related morbidity information on the standardized sheet developed by the research team. Research team members will make monthly phone calls to participants to remind them to perform this registration properly. Besides that, to minimize drop-outs to follow-up, the research team members will send email and phone reminders for patients about to come on-site to the 6-month follow-up assessment post-intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Prediabetes
Keywords
Diabetes Mellitus, Exercise, Health Education, Patient Education, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated to one of two interventions: Exercise Program (Ex) or Exercise and Lifestyle Education Program (ExLE).
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Program
Arm Type
Active Comparator
Arm Description
Ex: The participants will be submitted to only exercise sessions for 12 weeks.
Arm Title
Exercise and Lifestyle Education Program
Arm Type
Experimental
Arm Description
ExLE: The participants will be submitted to exercise sessions and education classes for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program
Intervention Description
The 12-week program consisting of 16 exercise sessions in a total of supervised and individually prescribed aerobic and muscle-strengthening exercise of approximately 60 minutes duration. The exercise sessions will be delivered as follow:
4 weeks - supervised exercise sessions 2x / week
8 weeks - supervised exercise sessions 1x / week
In addition, they will receive counseling for unsupervised exercise sessions in their community, to accumulate a minimum of 150 min/week.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Education Program
Intervention Description
The 12-week program consisting of 18 education classes of 30 minutes duration delivery by a health educator team. Participants receive a comprehensive education workbook to accompany the sessions, containing 20 chapters. The classes will be delivered as follow:
initial class to program introduction
4 weeks - education classes 2x / week
8 weeks - education classes 1x / week
final class to program graduation
Primary Outcome Measure Information:
Title
Functional capacity
Description
This outcome will be measured by the Incremental Shuttle Walk Test (ISWT) distance.
Time Frame
Change from Baseline Functional Capacity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Disease-related knowledge
Description
This outcome will be assessed from the total score of the Brazilian Portuguese version of the DiAbeTes Education Questionnaire (DATE-Q). This questionnaire is a 20-item self-administered tool (answer options are: true or false or do not know) equally distributed in five domains (self-management, long-term complications, being active, healthy eating, and psychosocial well-being) based on the Diabetes College. The total score ranges from 0 to 20, and higher scores indicate better disease-related knowledge.
Time Frame
Change from Baseline Disease-related knowledge at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment).
Secondary Outcome Measure Information:
Title
Health Behavior: health literacy
Description
This outcome will be measured by the Newest Vital Sign (NVS) tool score. This is a six-item toll regarding the information found on an accompanying nutrition label. Each correct response is worth one point with a total of six points possible. Scores equal or greater than four are evidence of adequate health literacy whereas scores below four are evidence of inadequate health literacy.
Time Frame
Change from Baseline health literacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Health Behavior: physical activity level
Description
This outcome will be measured from the total number of steps recorded by a pedometer during consecutive 7 days. For analysis of this outcome, the total number of steps recorded will be divided for seven in order to obtain the average number of steps/day for each participant. The level of physical activity will be classified from the average of steps/day, as follow: sedentary (<5000 steps/day); low active (5000-7499 steps/day); somewhat active (7500-9999 steps/day); active (≥10 000 steps/day) and highly active (>12 500 steps/day).
Time Frame
Change from Baseline physical activity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Health Behavior: exercise self-efficacy
Description
This outcome will be assessed from the total score of the Brazilian Portuguese version of Bandura's exercise self-efficacy scale. This is an 18-item self-administered tool which item contents are related to situations that may compromise the adherence to regular physical exercising, e. g. when feeling tired or during the holidays. The respondent should indicate from 0 (no confident) to 100 (very confident) how much confidence he or she has about maintaining the physical exercise routine face of the situation described in that item. The total score is the average from the eighteen items scores, and higher total scores indicate great exercise self-efficacy.
Time Frame
Change from Baseline Exercise Self-efficacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Health Behavior: adherence to standard Mediterranean food elements
Description
This outcome will be assessed from the total score of the Brazilian Portuguese version of the Mediterranean diet scale (MDS). The MDS has 13 items which quantitatively assess adherence to standard Mediterranean food elements [21]. The answer options are dichotomous: yes and no. Some questions have pictures and examples to help participants to answer the questions. One point is scored for each yes answered. Total scores range from 0 to 13. Scores below 5 indicate poor adherence to the MedDiet, and scores greater than 10 indicate high adherence.
Time Frame
Change from baseline adherence to standard Mediterranean food elements at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Health Behavior: medication adherence
Description
This outcome will be assessed from participants responses to a Likert Scale (scored from 1 (I do not or rarely use the prescribed medication) to 5 (I do always use the prescribed medication)) and by a five-item tool developed by the research team regarding the regular use of medicines with "yes" or "no" response options.
Time Frame
Change from Baseline Medication adherence at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Cardiometabolic Health Parameter: glycemic control
Description
This outcome will be assessed from the glycated hemoglobin (A1c) level obtained in routine tests dated no more than three months before the study assessment point.
Time Frame
Change from Baseline blood sugar level at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Cardiometabolic Health Parameter: anthropometric characteristics
Description
This outcome will be measured by the body mass index (BMI - kg/m2) and the waist circumference.
Time Frame
Change from Baseline BMI and waist circumference at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Cardiometabolic Health Parameter: cardiac autonomic control
Description
This outcome will be assessed from heart rate variability (HRV) indexes.
Time Frame
Change from Baseline Cardiac autonomic control at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Other Pre-specified Outcome Measures:
Title
Adherence program
Description
This outcome will be measured by the number of sessions attended in the program for each participant.
Time Frame
12 weeks (post-intervention assessment).
Title
Satisfaction with the program
Description
This outcome will be measured by questionnaires developed by the researchers. One questionnaire will assess the satisfaction with the exercise program and will be responded to by participants from the two programs (ExLE and Ex). The second one will assess the satisfaction with the learning tools of Diabetes College and will be responded only by participants of the Exercise and Lifestyle Education Program (ExLE).
Time Frame
12 weeks (post-intervention assessment) only to group 2 (Exercise and Lifestyle Education Program).
Title
Quality of life level
Description
Quality of life level will be evaluated using the the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). This questionnaire assesses 8 physical and mental health domains: Physical Functioning, Social Functioning, Role-Physical, Bodily Pain, Mental Health, Role-Emotional,Vitality and General Health. For each domain, item scores are coded, summed, and transformed, with final values (expressed as a percentage) ranging from 0 (worst health) to 100 (best health).
Time Frame
Change from Baseline Quality of life at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Depression
Description
This outcome will be measured by the Brazilian version of the Center for Epidemiological Scale - Depression (CESD). This is a 20-item tool used to rate how often the interviewed experienced symptoms associated with depression over the past week, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = rarely or none of the time, 1 = some or little of the time, 2 = moderately or much of the time, 3 = most or almost all the time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time Frame
Change from baseline depression at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Diet quality
Description
This outcome will be measured by a quantitative food frequency questionnaire (FFQ) at baseline (pre-intervention assessment) and 6 months pos-intervention (follow-up assessment) and by a qualitative FFQ at the end of 12-week intervention (post-intervention assessment). The quantitative FFD that will be used contains 92 items distributed in eight food groups ("cereals, tubers, roots, and derivatives"; "vegetables and legumes"; "fruits"; "beans"; "meat and eggs"; "milk and dairy products"; "oils and fats," and "sugars and sweets"), as well as 11 items investigating beverages and 1 item investigating food supplement.
Time Frame
Change from baseline diet quality at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Title
Morbidity associated with diabetes
Description
This outcome will be assessed through the participant's record during the 6-month follow-up regarding the following parameters: number of hospitalizations associated with diabetes, the occurrence of acute complications and diagnoses of chronic complications of diabetes.
Time Frame
6 months after post-intervention assessment (follow-up assessment).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (> 18 years old);
Clinical and laboratory diagnosis of Prediabetes or Diabetes Mellitus (type 1 or type 2);
Clinical compensation (glycemic control);
No cognitive limitation (score ≥ 4 in the six-item screener);
No confirmed diagnosis of cardiovascular diseases such as unstable coronary artery disease (CAD), heart failure; use of a pacemaker and/or implantable cardioverter-defibrillator (ICD), intermittent claudication; no recent cardiovascular event or cardiac surgery (≤ 6 months);
Participants not currently enrolled in a structured physical exercise program that follows diabetes guidelines.
Exclusion Criteria:
Clinical decompensation that contraindicates the performance of physical exercises (not glycemic control);
Physical and/or mental limitations that will prevent the participant to perform physical exercises and/or understanding of educational content;
Complex ventricular arrhythmias (i.e., atrial flutter or atrial fibrillation, multiple atrial or ventricular ectopy, and atrioventricular or ventricular block.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilian P da Silva, PhD
Organizational Affiliation
University Federal of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
31270-901
Country
Brazil
Facility Name
Hospital Universitário da UFJF
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36038330
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29222369
Citation
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Results Reference
background
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Sociedade Brasileira de Diabetes. 2017. "Diretrizes Da Sociedade Brasileira de Diabetes 2017-2018." (D): 257-63.
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29496507
Citation
Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
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Citation
Fiocco AJ, Scarcello S, Marzolini S, Chan A, Oh P, Proulx G, Greenwood C. The effects of an exercise and lifestyle intervention program on cardiovascular, metabolic factors and cognitive performance in middle-aged adults with type II diabetes: a pilot study. Can J Diabetes. 2013 Aug;37(4):214-219. doi: 10.1016/j.jcjd.2013.03.369. Epub 2013 Aug 2.
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Citation
Chaves GSDS, Ghisi GLM, Grace SL, Oh P, Ribeiro AL, Britto RR. Effects of comprehensive cardiac rehabilitation on functional capacity in a middle-income country: a randomised controlled trial. Heart. 2019 Mar;105(5):406-413. doi: 10.1136/heartjnl-2018-313632. Epub 2018 Oct 3.
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Citation
Machado CCDS, Malaguti C, Trevizan PF, Ezequiel DGA, Seixas MB, da Silva LP. Psychometric validation of the Brazilian Portuguese version of Bandura's exercise self-efficacy scale in diabetes patients. J Diabetes Metab Disord. 2020 Jul 15;19(2):925-932. doi: 10.1007/s40200-020-00581-6. eCollection 2020 Dec.
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Citation
Felix CMM, Ghisi GLM, Seixas MB, Batalha APDB, Ezequiel DGA, Trevizan PF, Pereira DAG, Silva LPD. Translation, cross-cultural adaptation, and psychometric properties of the Brazilian Portuguese version of the DiAbeTes Education Questionnaire (DATE-Q). Braz J Phys Ther. 2021 Sep-Oct;25(5):583-592. doi: 10.1016/j.bjpt.2021.03.003. Epub 2021 Mar 26.
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Results Reference
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Links:
URL
https://www.healtheuniversity.ca/EN/DiabetesCollege
Description
Diabetes College
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Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes
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