Concurrent Training and Metabolic Profile, Lung Function, Quality of Life and Stress

NCT04868240 | Completed DMC

• 2 other identifiers: FCDEF UC (CIDAF)2020.08759.BD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Lifestyle; Metabolic Disorders; Concurrent Exercise; Lung Function Decreased; Stress; Quality of Life; Office Worker

Outcome Measures

Primary Outcomes (10)

• 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).

  Baseline (Week 0) to follow-up (Week 16)

• 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).

  Baseline (Week 0) to follow-up (Week 16)

• Change from Baseline in the Fasting Insulin at Week 16

  Insuline will be expressed in mU/L.

  Baseline (Week 0) to follow-up (Week 16)

• 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.

  Baseline (Week 0) to follow-up (Week 16)

• Change from Baseline in Salivary Stress Hormones at Week 16

  Salivary levels of cortisol, α-amylase, immunoglobulin A, and Lysozyme will be analyzed.

  Baseline (Week 0) to follow-up (Week 16)

• 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.

  Baseline (Week 0) to follow-up (Week 16)

• 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).

  Baseline (Week 0) to follow-up (Week 16)

• 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.

  Baseline (Week 0) to follow-up (Week 16)

• 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).

  Baseline (Week 0) to follow-up (Week 16)

• 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".

  Baseline (Week 0) to follow-up (Week 16)

Secondary Outcomes (5)

• Change from Baseline in the Body Composition at Week 16

  Baseline (Week 0) to follow-up (Week 16)

• Change from Baseline in the Cardiorespiratory Fitness at Week 16

  Baseline (Week 0) to follow-up (Week 16)

• Change from Baseline in the Muscular Strength at Week 16

  Baseline (Week 0) to follow-up (Week 16)

• Change from Baseline in the Flexibility at Week 16

  Baseline (Week 0) to follow-up (Week 16)

• Change from Baseline in the Levels of Physical Activity at Week 16

  Baseline (Week 0) to follow-up (Week 16)

Other Outcomes (2)

• Maximal Dynamic Strength (Estimated 1 RM)

  Baseline (Week 0) to follow-up (Week 8)

• Assessment of Dietary Intake

  Baseline (Week 0) to follow-up (Week 16)

Study Arms (2)

Concurrent Training Group

EXPERIMENTAL

The experimental group will perform 16-weeks of the concurrent training exercise.

Behavioral: Concurrent training program

Control Group

NO INTERVENTION

Maintain their usual habits/activities, including not participate in any type of physical exercise.

Interventions

Concurrent training program BEHAVIORAL

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.

Concurrent Training Group

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Coimbra: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Fernanda Silva

Coimbra, Portugal

Location

Related Publications (4)

• Silva FM, Ferreira JP, Teixeira AM, Massart A, Duarte-Mendes P. Effects of combined aerobic-resistance training on health-related quality of life and stress in sedentary adults. Front Aging. 2025 Aug 18;6:1603635. doi: 10.3389/fragi.2025.1603635. eCollection 2025.

  PMID: 40900743 DERIVED

• Silva FM, Ferreira JP, Teixeira AM, Monteiro D, Duarte-Mendes P. The effect of smoking on lung function changes during a 16-week combined exercise program in middle-aged workers: a latent growth curve analysis. Eur J Appl Physiol. 2025 Nov;125(11):3223-3232. doi: 10.1007/s00421-025-05819-w. Epub 2025 May 31.

  PMID: 40448859 DERIVED

• Silva FM, Duarte-Mendes P, Ferreira JP, Carvalho E, Monteiro D, Massart A, Farinha C, Soares CM, Teixeira AM. Changes in Metabolic and Inflammatory Markers after a Combined Exercise Program in Workers: A Randomized Controlled Trial. Med Sci Sports Exerc. 2024 Nov 1;56(11):2156-2172. doi: 10.1249/MSS.0000000000003510. Epub 2024 Jun 27.

  PMID: 38934517 DERIVED

• 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.

  PMID: 35113957 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Metabolic Diseases; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Behavior; Nutritional and Metabolic Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Fernanda Silva

Model Details: Single-blinded two-arm RCT with parallel-groups (1:1 allocation ratio).

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 30, 2021
• Study Start: January 10, 2022
• Primary Completion: June 30, 2022
• Study Completion: September 10, 2022
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)