Sedentary LifestyleNCT04868240

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

A study testing Concurrent training program in people with Sedentary Lifestyle and Metabolic Disorders, run by University of Coimbra at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Sedentary Lifestyle, Metabolic Disorders, Concurrent Exercise
What is being tested?: Concurrent training program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 sitePortugal
Study dates: 10 Jan 2022to 10 Sep 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Fernanda Silva
Coimbra

Other trials in Portugal

About this study

Official title: Effects of Concurrent Training on Metabolic Profile, Lung Function, Quality of Life and Stress in Sedentary Adults: A Randomized Controlled Trial

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
Being tested: Concurrent training program
Medical subject headings: Sedentary Behavior, Metabolic Diseases, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Concurrent training programBehavioural
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.

Study groups in NCT04868240
Study group	Role	What they receive
Concurrent Training Group	Experimental	The experimental group will perform 16-weeks of the concurrent training exercise. Receives: Behavioral: Concurrent training program
Control Group	No intervention	Maintain their usual habits/activities, including not participate in any type of physical exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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".
Measured: Baseline (Week 0) to follow-up (Week 16)

Secondary outcomes (5)

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).
Measured: Baseline (Week 0) to follow-up (Week 16)
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.
Measured: Baseline (Week 0) to follow-up (Week 16)
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).
Measured: Baseline (Week 0) to follow-up (Week 16)
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.
Measured: Baseline (Week 0) to follow-up (Week 16)
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).
Measured: Baseline (Week 0) to follow-up (Week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202210 Sep 2022

First posted30 Apr 2021
Study start10 Jan 2022
Primary completion30 Jun 2022
Study completion10 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-blinded two-arm RCT with parallel-groups (1:1 allocation ratio).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04868240
Sponsor's protocol ID: FCDEF UC (CIDAF)
Other IDs: 2020.08759.BD
Status last verified: Feb 2024
First submitted: 24 Apr 2021
Last updated: 22 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40900743
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.
PubMed 40448859
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.
PubMed 38934517
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.
PubMed 35113957

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Concurrent Training on Metabolic Profile, Lung Function, Quality of Life and Stress in Sedentary Adults: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04868240
Acronym / sponsor ID: FCDEF UC (CIDAF)
Conditions: Sedentary Lifestyle, Metabolic Disorders, Concurrent Exercise, Lung Function Decreased, Stress, Quality of Life
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of CoimbraUniversity, hospital or other
Collaborators: Fundação para a Ciência e a Tecnologia
Study start: 10 Jan 2022 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 10 Sep 2022 (actual)
First posted: 30 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Single-blinded two-arm RCT with parallel-groups (1:1 allocation ratio).

Arm	Type	Receives
Concurrent Training Group	Experimental	Behavioral: Concurrent training programThe experimental group will perform 16-weeks of the concurrent training exercise.
Control Group	No intervention	–Maintain their usual habits/activities, including not participate in any type of physical exercise.

Who may qualify

Ages: 40 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Concurrent training programThe 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.	Behavioural	Concurrent Training Group

Primary outcome

Change from Baseline in the Lipid Profile at Week 16
Time frame: Baseline (Week 0) to follow-up (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
Time frame: Baseline (Week 0) to follow-up (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
Time frame: Baseline (Week 0) to follow-up (Week 16)
Insuline will be expressed in mU/L.
Change from Baseline in the Blood Pressure at Week 16
Time frame: Baseline (Week 0) to follow-up (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
Time frame: Baseline (Week 0) to follow-up (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
Time frame: Baseline (Week 0) to follow-up (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
Time frame: Baseline (Week 0) to follow-up (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
Time frame: Baseline (Week 0) to follow-up (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
Time frame: Baseline (Week 0) to follow-up (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
Time frame: Baseline (Week 0) to follow-up (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".

5 secondary outcomes

Change from Baseline in the Body Composition at Week 16
Time frame: Baseline (Week 0) to follow-up (Week 16)
Change from Baseline in the Cardiorespiratory Fitness at Week 16
Time frame: Baseline (Week 0) to follow-up (Week 16)
Change from Baseline in the Muscular Strength at Week 16
Time frame: Baseline (Week 0) to follow-up (Week 16)
Change from Baseline in the Flexibility at Week 16
Time frame: Baseline (Week 0) to follow-up (Week 16)
Change from Baseline in the Levels of Physical Activity at Week 16
Time frame: Baseline (Week 0) to follow-up (Week 16)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Derived from this study: PubMed 40900743Silva 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.
Derived from this study: PubMed 40448859Silva 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.
Derived from this study: PubMed 38934517Silva 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.
Derived from this study: PubMed 35113957Ferreira 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Concurrent training program in people with Sedentary Lifestyle and Metabolic Disorders, run by University of Coimbra at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Lipid Profile at Week 16 (time frame: Baseline (Week 0) to follow-up (Week 16)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04868240, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.