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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03489083
Other study ID # UFRGS 1.614.907
Secondary ID
Status Completed
Phase N/A
First received March 20, 2018
Last updated March 28, 2018
Start date February 1, 2016
Est. completion date March 1, 2018

Study information

Verified date March 2018
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 85 Years
Eligibility 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 Design


Intervention

Other:
Strength training
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.
No Training
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.

Locations

Country Name City State
Brazil Universidade Federal do Rio Grande do Sul Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heat Shock Response Change. 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 hs-CRP Change. Marker of Inflammation measured in mg/L. Before and After twelve weeks of exercise training.
Secondary Body composition Change. Body mass index (in Kg/m2). Before and After twelve weeks of exercise training.
Secondary TNF-a Change. Marker of Inflammation measured in pg/mL. Before and After twelve weeks of exercise training.
Secondary IL-10 Change. Marker of Inflammation measured in pg/mL. Before and After twelve weeks of exercise training.
Secondary Visceral Adipose Tissue Change. Amount of visceral adipose tissue measured in millimeters (mm). Before and After twelve weeks of exercise training.
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