Clinical trial NCT04868240: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Metabolic Disorders
Concurrent Exercise
Lung Function Decreased
Stress
Quality of Life
Office Worker
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2021-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded two-arm RCT with parallel-groups (1:1 allocation ratio).
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from Baseline in the Lipid Profile at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the Inflammatory Profile at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the Fasting Insulin at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the Blood Pressure at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in Salivary Stress Hormones at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the Spirometric Values at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the "Satisfaction with Life" at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the "Perceived Stress" at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the "36-Item Short Form Survey (SF-36)" at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the "World Health Organization Quality of Life Instruments - Bref" at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
Secondary outcomes:
measure: Change from Baseline in the Body Composition at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the Cardiorespiratory Fitness at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the Muscular Strength at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the Flexibility at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
measure: Change from Baseline in the Levels of Physical Activity at Week 16
timeFrame: Baseline (Week 0) to follow-up (Week 16)
Other outcomes:
measure: Maximal Dynamic Strength (Estimated 1 RM)
timeFrame: Baseline (Week 0) to follow-up (Week 8)
measure: Assessment of Dietary Intake
timeFrame: Baseline (Week 0) to follow-up (Week 16)
Locations:
city: Coimbra
country: Portugal
facility: Fernanda Silva
Study officials:
References:
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.