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The goal of this clinical trial is to compare the degree of effort during a resistance exercise session on blood glucose levels in individuals with prediabetes or type 2 diabetes mellitus. The main questions it aims to answer are:
Participants will perform 3 situations separated by at least 4 days, after being familiarized with all exercises and procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-effort session | Experimental | Participants will perform sets with as many repetitions they can each set. |
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| low-effort session | Experimental | Participants will perform sets with half of the anticipated number of repetitions of the high-effort session. |
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| Control session | Sham Comparator | The control session all procedures will be identical to the high-effort session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-effort session | Behavioral | Participants will perform 3 sets per exercise (total of 21 sets) with as many repetitions they can each set. We anticipate participants will perform ~10 repetitions per set in this session, with a total tempo of ~2.5 seconds per rep, averaging ~25 seconds per set. Resting period between exercises and sets will be 120 seconds. This will lead to a total session time of ~50 min. Their glycemic control will be evaluated during the following ~48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose concentration | Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device) | For 48 hours during each situation (arm) of the study |
| Glucose concentration | Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device) | For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study |
| Glucose concentration | Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device) | For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study |
| Glucose concentration | Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device) | For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study |
| Glucose concentration | Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device) | For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study |
| Time in range | Time of glucose concentration between 70 and 180 mg/dL (measured in minutes) | For 48 hours during each situation (arm) of the study |
| Time in range |
| Measure | Description | Time Frame |
|---|---|---|
| Resistance Training Intensity by the Omni Perceived Exertion Scale | Discrete scale from 0 to 10, where higher values mean more perceived exertion. | After each set of each exercise performed. |
| Feeling scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio De Castro Magalhaes, PhD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNM Exercise Physiology Lab | Albuquerque | New Mexico | 87131-0001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39499920 | Derived | Ramirez M, Gebauer M, Mermier C, Little JP, Lin L, Palley G, Hsiao YY, Mota Alvidrez RI, Mang ZA, Amorim FT, Tricoli V, De Castro Magalhaes F. The Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals Living With Prediabetes or Type 2 Diabetes: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 5;13:e63598. doi: 10.2196/63598. |
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For sharing the data generated we will use the Open Science Framework (OSF) platform. Before data sharing, all personal identifiers will be stripped from the data. Specifically, any direct identifiers (e.g., name, email addresses, phone and cell phone numbers), date identifiers (e.g., birthday, date of disease diagnosis, dates patients participated in data collection), location identifiers (e.g., personal or professional addresses, zip codes), links to external datasets identifiers (e.g., social media accounts) will be removed. Furthermore, participants will be represented by an ID string generated randomly (https://www.random.org/strings/), and their data will be inserted in the files in a random order, not associated with the order they were enrolled. Thus, data will be entirely de-identified before sharing, in order to protect sensitive personal information and privacy.
The anticipated date for data sharing will be 6 months after publication of data or 18 months after award end date, whatever happens first.
Freely accesible.
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized controlled, crossover, 3-way, clinical trial, following the SPIRIT and the TIDieR guidelines. After being considered eligible and agreeing to participate, participants will undergo anthropometrics assessment, familiarization sessions, and strength assessment before randomly carrying out 3 experimental (2 exercise and one control) periods, each composed of a total of ~48 hours, separated by at least 4 days. During the experimental periods diet will be strictly controlled and provided to the participants. Glycemic control will be assessed by a continuous glucose monitoring system throughout the experimental periods. The exercise sessions will be identical regarding total volume-load and session density, but proximity to failure in each set will be manipulated so effort will be different between the sessions. The control session will be identical in all procedures as the exercise sessions except that participants will remain sedentary.
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Data and statistical analysis will be performed by a researcher blinded to groups and participants' identities.
|
| Low-effort session | Behavioral | Participants will perform 6 sets per exercise (total of 42 sets) but perform half of the anticipated number of repetitions of the HIGH session (i.e., 5 reps). Repetition tempo at ~2.5 seconds will result in ~12.5 seconds per set. Resting period between exercises and sets will be 60 seconds. This prescription will also lead to a total session time of ~50 min. Thus, both the HIGH and LOW session will have similar total volume-load and session density, but differ in perceived effort after each set. Their glycemic control will be evaluated during the following ~48 hours. |
|
| Control | Behavioral | The control session all procedures will be identical to the HIGH session, with the exception of performing the resistance exercises. However, to simulate all other procedures participants will follow all instructions, be positioned on the equipment for the same amount of time as the HIGH session, but will not perform any repetition. Interval between fake sets and exercises will be 120 seconds. Their glycemic control will be evaluated during the following ~48 hours. |
|
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes) |
| For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study |
| Time in range | Time of glucose concentration between 70 and 180 mg/dL (measured in minutes) | For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study |
| Time in range | Time of glucose concentration between 70 and 180 mg/dL (measured in minutes) | For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study |
| Time in range | Time of glucose concentration between 70 and 180 mg/dL (measured in minutes) | For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study |
| Prevalence of hyperglycemia | Time of glucose concentrations >180 mg/dL (measured in minutes) | For 48 hours during each situation (arm) of the study |
| Prevalence of hyperglycemia | Time of glucose concentrations >180 mg/dL (measured in minutes) | For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study |
| Prevalence of hyperglycemia | Time of glucose concentrations >180 mg/dL (measured in minutes) | For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study |
| Prevalence of hyperglycemia | Time of glucose concentrations >180 mg/dL (measured in minutes) | For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study |
| Prevalence of hyperglycemia | Time of glucose concentrations >180 mg/dL (measured in minutes) | For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study |
| Prevalence of hypoglycemia | Time of glucose concentrations <70 mg/dL (measured in minutes) | For 48 hours during each situation (arm) of the study |
| Prevalence of hypoglycemia | Time of glucose concentrations <70 mg/dL (measured in minutes) | For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study |
| Prevalence of hypoglycemia | Time of glucose concentrations <70 mg/dL (measured in minutes) | For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study |
| Prevalence of hypoglycemia | Time of glucose concentrations <70 mg/dL (measured in minutes) | For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study |
| Prevalence of hypoglycemia | Time of glucose concentrations <70 mg/dL (measured in minutes) | For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study |
Discrete scale from -5 to +5, where higher values mean more positive feelings.
| Before and immediately after the resistance exercise sessions. |
| Physical Activity Enjoyment Scale | Scale composed of 18 items, with scores from 1 to 7 each (total score from 18 to 126). After analysis, higher scores mean higher enjoyment. | Immediately after the resistance exercise sessions. |
| Self-efficacy scale | Scale composed of 8 questions, with discrete options from 0 to 100%. Higher scores mean higher self-efficacy. | Immediately after the resistance exercise sessions. |
| Rating of Discomfort scale | Discrete scale from 0 to 100, where higher scores mean more discomfort. | Before and 5 minutes after the resistance exercise sessions. |
| Session rating of perceived exertion | Discrete scale from 0 to 10, where higher values mean more perceived exertion. | 5 minutes after the resistance exercise sessions. |
| D004700 | Endocrine System Diseases |