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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05362071
Other study ID # 55791622.8.0000.5313
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2022
Est. completion date September 15, 2023

Study information

Verified date September 2023
Source Federal University of Pelotas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study, characterized as a randomized clinical trial, aims to verify the effects of a remotely supervised exercise program, compared to a control group, on cardiometabolic, functional, and psychosocial outcomes in individuals with type 2 diabetes (DMT2). Males and females with T2DM from the city of Pelotas/RS who meet the study eligibility criteria will participate in the study. Participants will be randomized into the intervention group (IG) and control group (CG). The IG will perform a 12-week exercise program supervised remotely via video call, while GC will receive recommendations for physical activity. Participants will be evaluated at baseline (week 0) and after intervention (week 13). Initially, data for sample characterization, blood pressure, capillary blood glucose, and functional tests will collect during a home visit. In a second moment, participants will be invited to go to a specific laboratory for collecting glycated hemoglobin (HbA1c). Subsequently, a third date will be scheduled to apply self-administered questionnaires (online via GoogleDocs) related to the quality of life, sleep quality, depressive symptoms, emotional stress related to diabetes, level of physical activity, and eating habits. Additionally, acute glycemic responses will be evaluated before and immediately after an exercise session three times throughout the intervention. Capillary blood glucose will be collected in sessions performed in the initial period of mesocycles 1, 2, and 4. At week 13, reassessment will be realized by the same baseline assessors. Over the 12 weeks, a combined training will be carried out with remote supervision. Participants will perform strength exercises at usual and maximum execution speed and aerobic exercises at a rating of perceived effort between 11 and 15 on Borg's scale. The sessions will have a total duration between 37 and 57 min and a weekly frequency of two weekly sessions in the first six weeks and three weekly sessions in the remaining six weeks. Data will be expressed as mean and standard deviation. Data analysis between pre-and post-intervention moments, as well as between groups, will be performed by Generalized Estimated Equations, with Bonferroni post hoc, considering both per-protocol (including participants who meet 70% of frequency in the intervention) and intention to treat analysis (including all randomized participants), assuming an alpha level of 5%.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date September 15, 2023
Est. primary completion date August 14, 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - Being under medical treatment using oral hypoglycemic agents - Female and male patients with type 2 diabetes; - Not be involved with physical exercises in the last three months; - Being semi-literate. Exclusion Criteria: - Make use of insulin; - History of cardiovascular disease (except drug-controlled high blood pressure); - Presence of severe autonomic neuropathy, painful peripheral neuropathy or history of foot injuries, proliferative diabetic retinopathy, severe non-proliferative diabetic retinopathy; - Muscle or joint impairment that precludes performing physical exercises safely - Lack of internet access

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Remote Exercise Group
The intervention will have a weekly frequency of two sessions on non-consecutive days during the first six weeks and three sessions on non-consecutive days for the remaining six weeks. The exercise intervention will consist of four 3-week mesocycles. The session's structure will consist of a warm-up, the main part, in which a combined training program will be carried out, consisting of three distinct blocks, and at the end, stretching. Blocks 1 and 2 will consist of three strength exercises with bodyweight and alternative materials and aerobic training. Between blocks 1 and 2, and later in block 3, participants will take a free walk with displacement in the space they have available in their own home. The session will end with stretching exercises for the main muscle groups. The sessions will last 37 to 57 minutes over 12 weeks, with approximately 5 min of warm-up and stretching, and the main part ranging from 27 min to 47 min throughout the intervention.
Group control
Participants allocated to the GC will receive recommendations for the practice of physical activity based on information from three specific chapters of the Physical Activity Guide for the Brazilian Population (2021). The GC will receive through Whatsapp the information that is available in chapters 1, 4, and 5, which address the following topics: "Understanding Physical Activity," "Physical Activity for Adults," and "Physical Activity for the Elderly." If sending via Whatsapp is not possible, the booklet will be printed and delivered to the participant. At the end of the 12 weeks, the same booklet will be made available to IG participants.

Locations

Country Name City State
Brazil Federal University of Pelotas, Pelotas, Brazil Pelotas Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycaemic control Blood samples will be collected to be later performed a laboratory analysis regarding the HbA1c levels of each of the participants. Baseline (week 0) to Post-training (week 13)
Secondary Systolic blood pressure Measurements will be performed using a blood pressure monitor (HEM-7320, OMRON, China). Measurement will be performed on each participant's arm, and then two more measures on the arm with the highest value, always with a 1-minute interval between measurements. Baseline (week 0) to Post-training (week 13)
Secondary Diastolic blood pressure Measurements will be performed using a blood pressure monitor (HEM-7320, OMRON, China). Measurement will be performed on each participant's arm, and then two more measures on the arm with the highest value, always with a 1-minute interval between measurements. Baseline (week 0) to Post-training (week 13)
Secondary Capillary blood glucose Capillary blood glucose will be measured from blood samples (0.6 µL of blood) collected from the participants' fingertips using disposable lancets and reagent strips (Guide Accu-Check, São Paulo). After collection, blood samples will be immediately analyzed by a portable glucometer (Guide Accu-Check, Roche, São Paulo, Brazil). Baseline (week 0) to Post-training (week 13), and pre and immediately after an exercise session performed in the initial period of mesocycles 1, 2 and 4, in the IG participants (each mesocycle consists of 3 weeks).
Secondary Lower limb strength Lower limb strength will be measured by the 30-s chair stand functional test. The test will be performed in a chair standard, in which the participants will start seated with the feet flat the floor and the arms over the chest and will be instructed to stand up, standing completely, and soon after returning to the sitting position, repeating the crossed move as fast as possible. as many times as possible during 30s.The number of times the move is performed will be noted as a result of the test. Baseline (week 0) to Post-training (week 13)
Secondary Upper limb strength Upper limb strength will be measured by the Arm Curl test functional. The test will be performed in a chair, in which the participants will start seated with their feet flat on the floor and trunk fully leaning on the chair, holding a dumbbell with the dominant hand, 2 kg for women and 4 kg for men. Flexion of the forearm is requested, followed by extension, this movement is repeated for 30 seconds.The number of correctly performed push-ups are counted. Baseline (week 0) to Post-training (week 13)
Secondary Agility and dynamic balance Agility and dynamic balance will be measured using the time up and go (TUG) test. The test will start with the participants seated in a chair with a cone positioned in front of them 3 m away. Participants will be instructed to get up from their chair, walk as fast as possible without running, turn around the cone and return to the starting position. The shortest time of two attempts will be noted as a test result. In addition, the test will also be performed at usual walking speed. Baseline (week 0) to Post-training (week 13)
Secondary Aerobic capacity To measure the aerobic capacity of the participants, 2 minute step test will be used. The test measures the maximum number of knee raises that the individual can perform in 2 minutes.At the signal, the participant will begin stationary gait (without running), completing as many knee raises as possible within two minutes. The minimum knee height will be at a midpoint between the patella and the anterior superior iliac spine. The evaluator will count the number of elevations of the right knee. Baseline (week 0) to Post-training (week 13)
Secondary Flexibility To measure the flexibility of the lower limbs, the sit and reach (bank wells) test will be performed. Participants must be barefoot, then the will sit the base of the box, with the legs extended and together they will place one of the hands on the other and later will raise the arms vertically. When the evaluator gives the signal, the participant will lean the body forward and reach with the fingertips as much as possible on the graduated ruler, without bending the knees and without using rocking movements (insistence), the evaluator will record the result achieved. Baseline (week 0) to Post-training (week 13)
Secondary Quality of life (QOL) will be verified using the EUROHIS-QOL 8-item index Quality of life (QOL) will be verified using the EUROHIS-QOL 8-item index. The questionnaire was validated for the Brazilian population (PIRES et al., 2018). It consists of 8 items (general QoL, general health, energy, activities of daily living, self-esteem, social relationships, finances, and home); each item is answered individually, using a Likert-type scale, from 1 to 5 points. The score ranges from 8 to 40. A higher score indicates better individuals' perception of their QOL. Baseline (week 0) to Post-training (week 13)
Secondary Sleep quality will be verified using the Pittsburgh Sleep Quality Index Self-report Questionnaire Sleep quality will be verified using the Pittsburgh Sleep Quality Index Self-report Questionnaire (PSQI). The questionnaire includes 19 questions about the individual's perception and five questions about the roommates' perception related to the participant's sleep (if applicable). These questions are grouped into seven components, with scores ranging from zero to three, where higher scores indicate worse sleep quality (BERTOLAZI et al., 2011). Baseline (week 0) to Post-training (week 13)
Secondary Depressive symptoms Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9). This instrument was validated for the Brazilian population (SANTOS et al., 2013). It consists of nine questions with four answer options, and its purpose is to verify the presence of depressive symptoms in the last two weeks through a Likert-type scale from 0 to 3 points. The questionnaire also has the tenth question, referring to the interference of symptoms in daily life, and, in total, it is possible to have a score from 0 to 27, which indicates that the lower the score, the smaller the depressive symptoms. Baseline (week 0) to Post-training (week 13)
Secondary Emotional stress related to diabetes The Brazilian version of the Problem Areas in Diabetes Scale (B-PAID) (GROSS et al., 2007) will be used to analyze the emotional stress related to diabetes and the impact of diabetes and treatment on the study participants' lives. The questionnaire consists of questions focuses on the quality of life and emotional problems associated with living with diabetes and its treatment. A 5-point Likert scale produces a total score ranging from 0-100, where a high score indicates a high level of emotional distress. Baseline (week 0) to Post-training (week 13)
Secondary Physical activity levels Physical activity levels will be measured using the International Physical Activity Questionnaire in its short version (IPAQ-C). It consists of eight self-completion questions in different domains: work, leisure, domestic activities, and physical exercise. Data are expressed in minutes, and the metabolic equivalent is calculated (1 MET: 3.5 ml/kg/min) (PARDINIA et al., 2001). Baseline (week 0) to Post-training (week 13)
Secondary Eating habits The Food Frequency Questionnaire (FFQ) will be applied to investigate eating habits, as used in a previous study (GERAGE et al., 2017). The questionnaire consists of a list of 16 foods. According to the Brazilian Food Guide guidelines, these foods will be classified into natural/minimally processed foods and processed or ultra-processed foods. The frequency of consumption reported by the participants will generate scores, where higher scores indicate better eating habits. Baseline (week 0) to Post-training (week 13)
Secondary Subjective perception of well-being The subjective perception of well-being will be analyzed through a simple question: "in your opinion, how much did participation in the project improve your sense of general well-being?". This question will present structured responses based on the 5-point Likert Scale, ranging from "dissatisfied" to "very satisfied." Post-training (week 13)
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