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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
University of Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary Lifestyle

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 24, 2021
    Last Updated
    December 14, 2021
    Sponsor
    University of Coimbra
    Collaborators
    Fundação para a Ciência e a Tecnologia
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    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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