- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03489083
Heat Shock Response is Blunted in Elderly Diabetic People But Recovered by Strength Training
Heat-induced Extracellular HSP72 Release is Blunted in Elderly Diabetic People in Comparison With Healthy Middle-aged and Older Adults But is Partially Restored by Strength Training
The aim of this study was to compare the heat shock response (HSR) between healthy middle-aged adults, healthy elderly adults and type 2 diabetic elderly people. In addition, considering the effects of strength exercise in promoting health, we aimed to test the effects of strength training over the HSR in diabetic elderly people. Thirty (19 females and 11 males) sedentary non-smoking participants volunteered for this study (11 healthy middle-age adults, 7 healthy old adults and 12 diabetic old subjects, previously diagnosed by their personal physicians).
Firstly, venous blood samples were obtained from all participants to test the HSR. They were divided in three groups: healthy middle-age adults (45-59 y.o.), healthy elderly adults and elderly diabetic (> 60 y.o.). As we identify that diabetic people presented a poor HSR, we submit the diabetic group to a twelve-week resistance exercise training to verify if this intervention could improve the HS response.
Diabetic subjects were randomly (1:1 block randomization) allocated in one of the two groups: Trained and Control (no training). Strength training was performed three times per week while the control group performed a "placebo" stretching/relaxing session once a week (for adherence purposes). Both interventions had twelve weeks of duration. To avoid any significant adaptation, all stretching exercises (for large muscle groups only) were performed at very low intensity without any significant discomfort.
Supervised (by qualified sport and exercise scientists) exercise was performed in a gym on three non-consecutive days of the week. Each session lasted ~60 min and consisted of a warm up, the resistance exercise training and a cool down. The training programme consisted of a combination of upper and lower body exercises using gym equipments, free weights and body weight as the primary resistance. The twelve weeks of strength training were divided into three mesocycles of four weeks each. Exercises included leg press, knee extensions and leg curls, biceps curls, triceps extensions, lat pull-downs, shoulder press, bench press and abdominal crunch. Before the start of the training period, subjects completed a familiarization session to practice the exercises they would further perform during the training sessions, where the exercise load was individually tested. The resistance training was performed using two to three sets per exercise at intensities between 12-15 repetition maximum-RM.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90040-060
- Universidade Federal do Rio Grande do Sul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- . Inclusion criteria for diabetic people were HbA1c ≤ 7,5% (within the last six months), controlled blood pressure and no use of insulin.
Exclusion Criteria:
- Participants were excluded if they reported a history of myocardial infarction, cardiac illness, vascular disease, stroke, major systemic disease or any condition that would prevent them from engaging in an exercise study; or if they were already engaging in two or more planned and structured exercise sessions per week (in the last six months).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Trained Group
Subjects performing strength training three times per week for twelve weeks.
|
Strength training was performed three times per week for twelve weeks.
Supervised (by qualified sport and exercise scientists) exercise was performed in a gym on three non-consecutive days of the week.
Each session lasted ~60 min and consisted of a warm up, the resistance exercise training and a cool down.
The training programme consisted of a combination of upper and lower body exercises using gym equipments, free weights and body weight as the primary resistance.
The twelve weeks of strength training were divided into three mesocycles of four weeks each.
The resistance training was performed using two to three sets per exercise at intensities between 12-15 repetition maximum-RM.
|
|
Placebo Comparator: No Training Group
Subjects performing "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks.
|
Control group performed a "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks.
To avoid any significant adaptation, all stretching exercises (for large muscle groups only) were performed at very low intensity without any significant discomfort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heat Shock Response Change.
Time Frame: Before and After twelve weeks of exercise training.
|
Capacity of cells to express and export heat shock protein 72kDa in response to heat (ng/mL).
|
Before and After twelve weeks of exercise training.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hs-CRP Change.
Time Frame: Before and After twelve weeks of exercise training.
|
Marker of Inflammation measured in mg/L.
|
Before and After twelve weeks of exercise training.
|
|
Body composition Change.
Time Frame: Before and After twelve weeks of exercise training.
|
Body mass index (in Kg/m2).
|
Before and After twelve weeks of exercise training.
|
|
TNF-a Change.
Time Frame: Before and After twelve weeks of exercise training.
|
Marker of Inflammation measured in pg/mL.
|
Before and After twelve weeks of exercise training.
|
|
IL-10 Change.
Time Frame: Before and After twelve weeks of exercise training.
|
Marker of Inflammation measured in pg/mL.
|
Before and After twelve weeks of exercise training.
|
|
Visceral Adipose Tissue Change.
Time Frame: Before and After twelve weeks of exercise training.
|
Amount of visceral adipose tissue measured in millimeters (mm).
|
Before and After twelve weeks of exercise training.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFRGS 1.614.907
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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