NCT03489083

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Last Updated

April 5, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 20, 2018

Last Update Submit

March 28, 2018

Conditions

Keywords

DiabetesHeat Shock ResponseAgingExercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • hs-CRP Change.

    Before and After twelve weeks of exercise training.

  • Body composition Change.

    Before and After twelve weeks of exercise training.

  • TNF-a Change.

    Before and After twelve weeks of exercise training.

  • IL-10 Change.

    Before and After twelve weeks of exercise training.

  • Visceral Adipose Tissue Change.

    Before and After twelve weeks of exercise training.

Study Arms (2)

Trained Group

EXPERIMENTAL

Subjects performing strength training three times per week for twelve weeks.

Other: Strength training

No Training Group

PLACEBO COMPARATOR

Subjects performing "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks.

Other: No Training

Interventions

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.

Trained Group

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.

No Training Group

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90040-060, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The aim of this study was to compare the heat shock response (HSR) between healthy middle-aged adults (45-59 years old), healthy elderly adults (\> 60 y.o.) and type 2 diabetic elderly people (\> 60 y.o.). 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 5, 2018

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

April 5, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

All data, including HSR, body composition, inflammatory and oxidative stress markers and metabolites.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
After training completion
Access Criteria
All volunteers

Locations