Concurrent Training and Metabolic Profile, Lung Function, Quality of Life and Stress
Primary Purpose
Sedentary Lifestyle, Metabolic Disorders, Concurrent Exercise
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Concurrent training program
Sponsored by
About this trial
This is an interventional prevention trial for Sedentary Lifestyle
Eligibility Criteria
Inclusion Criteria:
- Men and women with ages between 40 to 64 years old
- Physically inactive adults
- Full-time workers in a sedentary job
- BMI between 18 and 35 kg/m2
- Maintain the current diet and undergo all testing procedures
Exclusion Criteria:
- Chronic disease (e.g., diabetes, cardiovascular disease, pulmonary disease)
- Cognitive impairments and/or psychiatric conditions that could interfere with the study outcomes
- Take any medication that could interfere with the study outcomes
- Limitations that prevent them from practicing exercise
- History of heart failure/myocardial infarction
- Uncontrolled or abnormal blood pressure
- Smokers
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Concurrent Training Group
Control Group
Arm Description
The experimental group will perform 16-weeks of the concurrent training exercise.
Maintain their usual habits/activities, including not participate in any type of physical exercise.
Outcomes
Primary Outcome Measures
Change from Baseline in the Lipid Profile at Week 16
The levels of total cholesterol, LDL-C, HDL-C, triglycerides, HbA1c, and glucose will be analyzed. These outcome measures have the same units of measure (mg/dL).
Change from Baseline in the Inflammatory Profile at Week 16
The cytokines IL-1β, IL-1ra, IL-10, IL-6, TNF-α, TGF-β, adiponectin and leptin will be analyzed. These outcome measures have the same units of measure (pg/ml).
Change from Baseline in the Fasting Insulin at Week 16
Insuline will be expressed in mU/L.
Change from Baseline in the Blood Pressure at Week 16
The systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) will be measure through an automated oscillometric cuff.
Change from Baseline in Salivary Stress Hormones at Week 16
Salivary levels of cortisol, α-amylase, immunoglobulin A, and Lysozyme will be analyzed.
Change from Baseline in the Spirometric Values at Week 16
Spirometry will be performed to obtain the Forced Vital Capacity, Peak Expiratory Flow, and Forced Expiratory Volume in 1s.
These outcome measures have the same units of measure, i.e., %predicted.
Change from Baseline in the "Satisfaction with Life" at Week 16
The "Satisfaction with Life Scale" questionnaire consists of 5-item formulated in the positive sense, that are answered using a 7-point Likert scale, where 1=strongly disagree and 7= strongly agree. Final scores range between 5 (low satisfaction) to 35 (high satisfaction).
Change from Baseline in the "Perceived Stress" at Week 16
The Perceived Stress Scale measures the perception of stress. Seven out of the 14-items are considered negative and seven as positive rated on a 5-point Likert scale. Final scores range between 0 to 56 points, with a higher score representing higher stress.
Change from Baseline in the "36-Item Short Form Survey (SF-36)" at Week 16
The 36-Item Short Form Survey is a generic instrument to evaluate health-related quality of life. SF-36 comprises 36 questions that cover 8 domains of health. Response choices for the items were on 2-, 3-, 5- or 6-point scales. Two-component scores are derived from 8 subdomains: a physical component (PC) and a mental component (MC). Higher scores on all subscales represent better health and functioning (>50).
Change from Baseline in the "World Health Organization Quality of Life Instruments - Bref" at Week 16
The World Health Organization Quality of Life Instruments - Bref, assesses the subjective quality of life and consists of 26 questions with responses on a 5-point Likert scale. Each domain is made up of questions where the scores vary between 1 and 5. The mean score in each domain represents the perception of the subject of their satisfaction with each aspect of quality of life. The higher the score, the better is their perception. There are no cut-points above or below which quality of life could be classified as "poor" or "good".
Secondary Outcome Measures
Change from Baseline in the Body Composition at Week 16
Body weight (kg) and stature (cm) will be assessed to report BMI in kg/m^2. Values of skeletal muscle mass (kg) and fat mass (kg) will be determined using the tetrapolar bioimpedance (Inbody 270, USA).
Change from Baseline in the Cardiorespiratory Fitness at Week 16
Cardiorespiratory fitness will be assessed by the "Chester Step Test". The maximum test duration is 10 minutes (Level 5). VO2Max will be calculated by the CST software and expressed in mlso2/kg/min.
Change from Baseline in the Muscular Strength at Week 16
Handgrip strength will be measured by Jamar hand dynamometer. The test will be repeated twice with each hand. The score is the highest of the two readings (to the nearest kg).
Change from Baseline in the Flexibility at Week 16
Arms flexibility will be assessed by "Back Scratch test". Two attempts will be carried out on each side, and the result is the mean of the two measures.
Legs flexibility will be assessed by "Modified Sit-and-reach test". Two measurements will be performed, and the result is the mean of the two measures.
Change from Baseline in the Levels of Physical Activity at Week 16
Sedentary time and physical activity levels (light, moderate and vigorous) will be assessed using a triaxial accelerometer (ActiGraph GT3X, US).
These outcome measures have the same units of measure (min/day).
Full Information
NCT ID
NCT04868240
First Posted
April 24, 2021
Last Updated
December 14, 2021
Sponsor
University of Coimbra
Collaborators
Fundação para a Ciência e a Tecnologia
1. Study Identification
Unique Protocol Identification Number
NCT04868240
Brief Title
Concurrent Training and Metabolic Profile, Lung Function, Quality of Life and Stress
Official Title
Effects of Concurrent Training on Metabolic Profile, Lung Function, Quality of Life and Stress in Sedentary Adults: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 10, 2022 (Anticipated)
Primary Completion Date
February 10, 2022 (Anticipated)
Study Completion Date
September 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
Collaborators
Fundação para a Ciência e a Tecnologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Physical inactivity and sedentary time are highly prevalent worldwide and are associated with many adverse health outcomes. Workers adults spend two-thirds of their workday sitting, so they are particularly at risk. Exercise is considered a preventive and treatment tool for diseases, however, the effects of Concurrent Training (that is, aerobic plus resistance training) are not well established in healthy adults.
This research project aims to analyze the effects of a concurrent training program on metabolic profile, lung function, stress and quality of life, as well as body composition and physical fitness in sedentary adults.
This is a single-blinded two-arm RCT with parallel groups. After completion of baseline assessments, eligible participants will be randomized in a 1:1 ratio to participate in concurrent training group or control group. Repeat assessments will be taken immediately post 8 weeks and post 16 weeks of intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Metabolic Disorders, Concurrent Exercise, Lung Function Decreased, Stress, Quality of Life, Office Worker
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blinded two-arm RCT with parallel-groups (1:1 allocation ratio).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concurrent Training Group
Arm Type
Experimental
Arm Description
The experimental group will perform 16-weeks of the concurrent training exercise.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Maintain their usual habits/activities, including not participate in any type of physical exercise.
Intervention Type
Behavioral
Intervention Name(s)
Concurrent training program
Intervention Description
The experimental group will perform 16-weeks of exercise. The exercise sessions will occur three times/week.
The participants should conduct their daily activities as usual outside of the study and maintain the same diet.
Primary Outcome Measure Information:
Title
Change from Baseline in the Lipid Profile at Week 16
Description
The levels of total cholesterol, LDL-C, HDL-C, triglycerides, HbA1c, and glucose will be analyzed. These outcome measures have the same units of measure (mg/dL).
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the Inflammatory Profile at Week 16
Description
The cytokines IL-1β, IL-1ra, IL-10, IL-6, TNF-α, TGF-β, adiponectin and leptin will be analyzed. These outcome measures have the same units of measure (pg/ml).
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the Fasting Insulin at Week 16
Description
Insuline will be expressed in mU/L.
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the Blood Pressure at Week 16
Description
The systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) will be measure through an automated oscillometric cuff.
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in Salivary Stress Hormones at Week 16
Description
Salivary levels of cortisol, α-amylase, immunoglobulin A, and Lysozyme will be analyzed.
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the Spirometric Values at Week 16
Description
Spirometry will be performed to obtain the Forced Vital Capacity, Peak Expiratory Flow, and Forced Expiratory Volume in 1s.
These outcome measures have the same units of measure, i.e., %predicted.
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the "Satisfaction with Life" at Week 16
Description
The "Satisfaction with Life Scale" questionnaire consists of 5-item formulated in the positive sense, that are answered using a 7-point Likert scale, where 1=strongly disagree and 7= strongly agree. Final scores range between 5 (low satisfaction) to 35 (high satisfaction).
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the "Perceived Stress" at Week 16
Description
The Perceived Stress Scale measures the perception of stress. Seven out of the 14-items are considered negative and seven as positive rated on a 5-point Likert scale. Final scores range between 0 to 56 points, with a higher score representing higher stress.
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the "36-Item Short Form Survey (SF-36)" at Week 16
Description
The 36-Item Short Form Survey is a generic instrument to evaluate health-related quality of life. SF-36 comprises 36 questions that cover 8 domains of health. Response choices for the items were on 2-, 3-, 5- or 6-point scales. Two-component scores are derived from 8 subdomains: a physical component (PC) and a mental component (MC). Higher scores on all subscales represent better health and functioning (>50).
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the "World Health Organization Quality of Life Instruments - Bref" at Week 16
Description
The World Health Organization Quality of Life Instruments - Bref, assesses the subjective quality of life and consists of 26 questions with responses on a 5-point Likert scale. Each domain is made up of questions where the scores vary between 1 and 5. The mean score in each domain represents the perception of the subject of their satisfaction with each aspect of quality of life. The higher the score, the better is their perception. There are no cut-points above or below which quality of life could be classified as "poor" or "good".
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Secondary Outcome Measure Information:
Title
Change from Baseline in the Body Composition at Week 16
Description
Body weight (kg) and stature (cm) will be assessed to report BMI in kg/m^2. Values of skeletal muscle mass (kg) and fat mass (kg) will be determined using the tetrapolar bioimpedance (Inbody 270, USA).
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the Cardiorespiratory Fitness at Week 16
Description
Cardiorespiratory fitness will be assessed by the "Chester Step Test". The maximum test duration is 10 minutes (Level 5). VO2Max will be calculated by the CST software and expressed in mlso2/kg/min.
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the Muscular Strength at Week 16
Description
Handgrip strength will be measured by Jamar hand dynamometer. The test will be repeated twice with each hand. The score is the highest of the two readings (to the nearest kg).
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the Flexibility at Week 16
Description
Arms flexibility will be assessed by "Back Scratch test". Two attempts will be carried out on each side, and the result is the mean of the two measures.
Legs flexibility will be assessed by "Modified Sit-and-reach test". Two measurements will be performed, and the result is the mean of the two measures.
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Title
Change from Baseline in the Levels of Physical Activity at Week 16
Description
Sedentary time and physical activity levels (light, moderate and vigorous) will be assessed using a triaxial accelerometer (ActiGraph GT3X, US).
These outcome measures have the same units of measure (min/day).
Time Frame
Baseline (Week 0) to follow-up (Week 16)
Other Pre-specified Outcome Measures:
Title
Maximal Dynamic Strength (Estimated 1 RM)
Description
Experimental group participants will perform incremental loading tests to estimated 1 RM in free weights exercises.
Time Frame
Baseline (Week 0) to follow-up (Week 8)
Title
Assessment of Dietary Intake
Description
Dietary habits will be assessed using a semi-quantitative Food Frequency Questionnaire.
Time Frame
Baseline (Week 0) to follow-up (Week 16)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women with ages between 40 to 64 years old
Physically inactive adults
Full-time workers in a sedentary job
BMI between 18 and 35 kg/m2
Maintain the current diet and undergo all testing procedures
Exclusion Criteria:
Chronic disease (e.g., diabetes, cardiovascular disease, pulmonary disease)
Cognitive impairments and/or psychiatric conditions that could interfere with the study outcomes
Take any medication that could interfere with the study outcomes
Limitations that prevent them from practicing exercise
History of heart failure/myocardial infarction
Uncontrolled or abnormal blood pressure
Smokers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M. Silva
Phone
+321969999999
Email
geral.fernandasilva@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
University of Coimbra
Phone
239 802 770
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35113957
Citation
Ferreira JP, Duarte-Mendes P, Teixeira AM, Silva FM. Effects of combined training on metabolic profile, lung function, stress and quality of life in sedentary adults: A study protocol for a randomized controlled trial. PLoS One. 2022 Feb 3;17(2):e0263455. doi: 10.1371/journal.pone.0263455. eCollection 2022.
Results Reference
derived
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Concurrent Training and Metabolic Profile, Lung Function, Quality of Life and Stress
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