Hybrid Exercise Training for Health, Performance and Well-Being (DoIT II)

January 4, 2022 updated by: Ioannis G. Fatouros, University of Thessaly

The Dose-response Effect of High-intensity Interval Neuromuscular Training on Health, Performance and Quality of Life in Overweight/Obese Adults: The DoIT Trial

Observing a lack of research investigating the chronic physiological and psychological responses to this type of exercise training the aim of this study is to investigate the optimal training configurations of DoIT to produce positive effects on health, performance and quality of life markers in sedentary overweight or obese adults aged 30-55 years. The DoIT program will be performed in a small-group setting indoor or outdoor implementing a progressive manner for 12 months and using bodyweight exercises with alternative modes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This controlled, randomized, four-group, repeated-measures clinical trial will be consisted of the following stages:

  1. Initial testing: body weight and height, RMR, daily physical activity (PA), daily nutritional intake.
  2. a 4-week adaptive period: based on a dietary analysis, participants will be given a dietary plan (considering the RMR and total daily physical activity related energy expenditure), providing an isocaloric diet over the initial 4-week adaptive period. During this adaptive period, volunteers will also be familiarized with exercises techniques and overload patterns that will be used throughout the study through 4 preparatory sessions.
  3. At the end of the adaptation period, participants will participate in assessment procedures (baseline testing) at University facilities.
  4. After the adaptive period all participants will be randomly assigned to four groups (control, 1 session/week, 2 sessions/week, 3 sessions/week). The exercise protocols that will be used throughout the 1-year intervention will be consisted of 8-12 neuromotor exercises in circuit fashion applying prescribed time (15-45 sec) of effort and passive recovery intervals.
  5. After 12 months of exercise intervention all participants will participate in assessment procedures (post-training testing) at University facilities within 5 days after the completion of the last training session.

All participants will be randomly assigned to the following four groups:

  1. Control group (no training)
  2. DoIT-1 (1 session/week)
  3. DoIT-2 (2 sessions/week)
  4. DoIT-3 (3 sessions/week)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Trikala, Greece, 42100
        • Laboratory of Exercise Physiology, Exercise Biochemistry and Sports Nutrition, School of Physical Education, Sports Sciences and Dietetics, University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. inactivity (no exercise participation for ≥6 months before the study; VO2max <30 ml·kg-1·min-1)
  2. age of 30-55 years
  3. overweight/obese (BMI 25.0-39.9)
  4. body fat percentage for women > 32% and for men > 25%
  5. waist circumference for women > 80 cm and for men > 94 cm
  6. medical clearance for strenuous physical training
  7. no smoking for ≥6 months before the study
  8. no diet intervention or usage of nutritional supplements/medications before (≥6 months) and during the study
  9. no weight loss greater >10% of body mass before (≤6 months) the study
  10. no diagnosis or symptoms of cardiovascular, metabolic, pulmonary, renal, musculoskeletal or mental disorders

Exclusion Criteria:

Participants will be excluded from the study if they:

  1. will not participate in ≥80% of total exercise sessions
  2. will adhere to a nutritional intervention during the study
  3. will modify the habitual physical activity levels during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Control
No intervention. Participated only in measurements at baseline, at 6 months and at 12 months.
Behavioral: Control
No training will be performed during a 1-year period. Participation only in measurements.
EXPERIMENTAL: DoIT-1
Participated in a supervised 1-year workout exercise training program once per week and in measurements at baseline, at 6 months and at 12 months.
Behavioral: DoIT-1
A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed once per week on non-consecutive days for 12 months.
Other Names:
  • Hybrid Interval Training
EXPERIMENTAL: DoIT-2
Participated in a supervised 1-year workout exercise training program twice per week and in measurements at baseline, at 6 months and at 12 months.
Behavioral: DoIT-2
A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed twice per week on non-consecutive days for 12 months.
Other Names:
  • Hybrid Interval Training
EXPERIMENTAL: DoIT-3
Participated in a supervised 1-year workout exercise training program thrice per week and in measurements at baseline, at 6 months and at 12 months.
Behavioral: DoIT-3
A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed thrice per week on non-consecutive days for 12 months.
Other Names:
  • Hybrid Interval Training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in body mass
Time Frame: At baseline, at 6 months and at 12 months
Body mass (kg) will be measured using a beam scale
At baseline, at 6 months and at 12 months
Change in body mass index
Time Frame: At baseline, at 6 months and at 12 months
Body mass index will be calculated using the Quetelet's equation
At baseline, at 6 months and at 12 months
Change in waist circumference
Time Frame: At baseline, at 6 months and at 12 months
Waist circumference (cm) will be measured using a Gullick II tape
At baseline, at 6 months and at 12 months
Change in hip circumference
Time Frame: At baseline, at 6 months and at 12 months
Hip circumference (cm) will be measured using a Gullick II tape
At baseline, at 6 months and at 12 months
Change in waist-to-hip ratio
Time Frame: At baseline, at 6 months and at 12 months
Waist-to-hip ratio will be calculated by dividing the waist by the hip measurement
At baseline, at 6 months and at 12 months
Change in body fat
Time Frame: At baseline and at 12 months
Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
At baseline and at 12 months
Change in fat mass
Time Frame: At baseline and at 12 months
Body fat (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
At baseline and at 12 months
Change in fat-free mass
Time Frame: At baseline and at 12 months
Fat-free mass (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
At baseline and at 12 months
Change in resting metabolic rate (RMR)
Time Frame: At baseline, at 6 months and at 12 months
RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system
At baseline, at 6 months and at 12 months
Change in maximal strength (1RM)
Time Frame: At baseline, at 6 months and at 12 months
1RM (kg) for the lower body will be measured bilaterally on a horizontal leg press, seated leg extension and lying leg curl machines while 1RM (kg) for the upper body will be measured on a seated chest press and lat pull-down machines
At baseline, at 6 months and at 12 months
Change in maximal oxygen consumption (VO2max)
Time Frame: At baseline, at 6 months and at 12 months
VO2max (ml/kg/min) will be estimated using a low-risk, low-cost and single-stage submaximal treadmill walking test
At baseline, at 6 months and at 12 months
Change in habitual physical activity (PA)
Time Frame: At baseline, at 3, 6, 9 and 12 months
Seven-day habitual PA (MET-min/week) will be assessed using the International Physical Activity Questionnaire (IPAQ)
At baseline, at 3, 6, 9 and 12 months
Change in dietary intake
Time Frame: At baseline, at 3, 6, 9 and 12 months
Dietary intake (kcal) will be assessed using 7-day diet recalls
At baseline, at 3, 6, 9 and 12 months
Change in body mass content (BMC)
Time Frame: At baseline and at 12 months
BMC (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.
At baseline and at 12 months
Change in body mass density (BMD)
Time Frame: At baseline and at 12 months
BMD (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.
At baseline and at 12 months
Change in resting systolic (SBP) and diastolic (DBP) blood pressures.
Time Frame: At baseline, at 6 months and at 12 months
Resting SBP (mmHg) and DBP (mmHg) will be assessed by a manual sphygmomanometer
At baseline, at 6 months and at 12 months
Change in mean arterial pressure (MAP).
Time Frame: At baseline, at 6 months and at 12 months
MAP (mmHg) will be calculated using the following equation: MAP = SBP + (DBP × DBP) / 3
At baseline, at 6 months and at 12 months
Change in resting heart rate (RHR).
Time Frame: At baseline, at 6 months and at 12 months
RHR (bpm) will be measured by pulse palpation for 60 seconds.
At baseline, at 6 months and at 12 months
Change in muscular endurance
Time Frame: At baseline, at 6 months and at 12 months
Muscular endurance (repetitions until muscle failure) will be assessed using timed tests (60 sec) for the abdominal musculature, upper and lower body. The tests will include partial curl-up, push-up for males and modified push-up for females (kneeling position) and modified chair squat, respectively
At baseline, at 6 months and at 12 months
Change in flexibility
Time Frame: At baseline, at 6 months and at 12 months
Flexibility (cm) will be assessed using the modified sit-and-reach test
At baseline, at 6 months and at 12 months
Change in static balance
Time Frame: At baseline, at 6 months and at 12 months
Static balance (sec) will be assessed using the Sharpened Romberg test
At baseline, at 6 months and at 12 months
Change in functional capacity
Time Frame: At baseline, at 6 months and at 12 months
Functional capacity will be assessed using a movement-based screening tool titled Functional Movement Screening (FMS). The FMS will be consisted of 7 movement tasks that will be scored from 0 to 3 points and the sum will create score ranging from 0 to 21 points (0 = pain with pattern regardless of quality, 1 = unable to perform pattern, 2 = able to perform pattern with compensation/imperfection, 3 = able to perform pattern as directed).
At baseline, at 6 months and at 12 months
Change in blood lipids
Time Frame: At baseline and at 12 months
Total serum cholesterol (mmol/L), triglycerides (mmol/L), low-density lipoprotein (mmol/L) and high-density lipoprotein (mmol/L) will be measured with commercially availlable kits
At baseline and at 12 months
Change in blood inflammatory markers
Time Frame: At baseline and at 12 months
Cytokines, lipocalines, CRP, oxidative stress markers will be measured with commercially availlable kits
At baseline and at 12 months
Change in cortisol
Time Frame: At baseline and at 12 months
Cortisol (nmol/L) will be measured with commercially availlable kits
At baseline and at 12 months
Change in insulin
Time Frame: At baseline and at 12 months
Insulin (mIU/L) will be measured with commercially availlable kits
At baseline and at 12 months
Change in homeostatic model assessment for insulin resistance (HOMA-IR)
Time Frame: At baseline and at 12 months
HOMA-IR will be measured with commercially availlable kits. ΗΟΜΑ score will be calculated using the equation HOMA-IR = fasting insulin (mIU/L) x fasting glucose (mg/dL) / 405. HOMA-IR score will be classified using the following range: normal insulin resistance < 3, moderate insulin resistance 3-5, severe insulin resistance > 5)
At baseline and at 12 months
Change in leptin
Time Frame: At baseline and at 12 months
Leptin (μg/L) will be measured with commercially availlable kits
At baseline and at 12 months
Change in adiponectin
Time Frame: At baseline and at 12 months
Adiponectin (μg/mL) will be measured with commercially availlable kits
At baseline and at 12 months
Change in interleukin 1 beta (IL-1b) and interleuking 6 (IL-6)
Time Frame: At baseline and at 12 months
IL-1b and IL-6 (pg/ml) will be measured with commercially availlable kits
At baseline and at 12 months
Change in fasting blood glucose (FBG)
Time Frame: At baseline and at 12 months
FBG (mg/dL) will be measured with commercially availlable kits
At baseline and at 12 months
Change in serum protein carbonyl levels
Time Frame: At baseline and at 12 months
Protein carbonyl (mg) will be measured with commercially availlable kits
At baseline and at 12 months
Change in thiobarbituric acid-reactive substances (TBARS)
Time Frame: At baseline and at 12 months
TBARS (nmol/mg protein) will be measured with commercially availlable kits
At baseline and at 12 months
Change in reduced (GSH) and oxidized (GSSG) glutathione
Time Frame: At baseline and at 12 months
GSH and GSSG (nmol/L) will be measured with commercially availlable kits
At baseline and at 12 months
Change in catalase activity
Time Frame: At baseline and at 12 months
Catalase activity (units) will be measured with commercially availlable kits
At baseline and at 12 months
Change in total antioxidant capacity (TAC)
Time Frame: At baseline and at 12 months
TAC (mmol/l) will be measured with commercially availlable kits
At baseline and at 12 months
Change in C-reactive protein (CRP)
Time Frame: At baseline and at 12 months
CRP (mg/L) will be measured with commercially availlable kits
At baseline and at 12 months
Change in cholecystokinin (CKK)
Time Frame: At baseline and at 12 months
CKK (ng/ml) will be measured with commercially availlable kits
At baseline and at 12 months
Change in pancreatic polypeptide (PP)
Time Frame: At baseline and at 12 months
PP (pg/ml) will be measured with commercially availlable kits
At baseline and at 12 months
Change in peptide YY (PYY)
Time Frame: At baseline and at 12 months
PYY (ng/ml) will be measured with commercially availlable kits
At baseline and at 12 months
Change in oxyntomodulin (OXM)
Time Frame: At baseline and at 12 months
OXM (pg/ml) will be measured with commercially availlable kits
At baseline and at 12 months
Change in ghrelin
Time Frame: At baseline and at 12 months
Ghrelin (pg/ml) will be measured with commercially availlable kits
At baseline and at 12 months
Change in glucagon-like peptide-1 (GLP-1)
Time Frame: At baseline and at 12 months
GLP-1 (pg/ml) will be measured with commercially availlable kits
At baseline and at 12 months
Change in appetite
Time Frame: At baseline, at 6 months and at 12 months
The Visual Analog Scale (VAS) will be used to measure perceived hunger, satiety, and individual's own interpretation of their hunger sensations. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best).
At baseline, at 6 months and at 12 months
Change in quality of life
Time Frame: At baseline, at 6 months and at 12 months
Quality of life will be assessed using the physical and mental component subscales of the Greek 36-Item Short-Form Health Survey (SF-36). The scores on both component subscales of the SF-36 will range from 0 to 100, with higher scores indicating better health status while the minimal clinically important difference will be 2 points.
At baseline, at 6 months and at 12 months
Change in exercise enjoyment
Time Frame: At baseline, at 6 months and at 12 months
Exercise enjoyment will be assessed using the Exercise Enjoyment Scale (EES), which is a single-item 7-point scale to assess enjoyment pre-, during, and post-exercise ranging from "not at all" at 1 to "extremely" at 7.
At baseline, at 6 months and at 12 months
Change in affective valence
Time Frame: At baseline, at 6 months and at 12 months
Affective responses to exercise will be assessed using the Feeling Scale (FS), which is a single-item 11-point scale to assess feeling of pleasure pre-, during, and post-exercise training ranging from "very good" at -5 to "very bad" at 5.
At baseline, at 6 months and at 12 months
Change in irisin
Time Frame: At baseline and at 12 months
Irisin (ng/ml) will be measured with commercially availlable kits
At baseline and at 12 months
Change in left ventricular end-diastolic volume (LVEDV).
Time Frame: At baseline and at 12 months
LVEDV (ml) will be measured using echocardiography.
At baseline and at 12 months
Change in left ventricular end-systolic volume (LVESV).
Time Frame: At baseline and at 12 months
LVESV (ml) will be measured using echocardiography.
At baseline and at 12 months
Change in left ventricular stroke volume (LVSV).
Time Frame: At baseline and at 12 months
LVSV (ml) will be measured using echocardiography.
At baseline and at 12 months
Change in interventricular septum end diastole (IVSd).
Time Frame: At baseline and at 12 months
IVSd (mm) will be measured using echocardiography.
At baseline and at 12 months
Change in interventricular septum end diastole (IVSs).
Time Frame: At baseline and at 12 months
IVSs (mm) will be measured using echocardiography.
At baseline and at 12 months
Change in left ventricular ejection fraction (LVEF).
Time Frame: At baseline and at 12 months
LVEF (%) will be measured using echocardiography.
At baseline and at 12 months
Change in left ventricular internal diameter end diastole (LVIDd).
Time Frame: At baseline and at 12 months
LVIDd (mm) will be measured using echocardiography.
At baseline and at 12 months
Change in left ventricular internal diameter end systole (LVIDs).
Time Frame: At baseline and at 12 months
LVIDs (mm) will be measured using echocardiography.
At baseline and at 12 months
Change in left ventricular posterior wall end diastole (LVPWd).
Time Frame: At baseline and at 12 months
LVPWd (mm) will be measured using echocardiography.
At baseline and at 12 months
Change in left ventricular mass (LV mass).
Time Frame: At baseline and at 12 months
LV mass (g) will be measured using echocardiography.
At baseline and at 12 months
Change in left atrial (LA) diameter.
Time Frame: At baseline and at 12 months
LA diameter (mm) will be measured using echocardiography.
At baseline and at 12 months
Change in aortic root.
Time Frame: At baseline and at 12 months
Aortic root (mm) will be measured using echocardiography.
At baseline and at 12 months
Change in aortic valve velocity (AoV Vel).
Time Frame: At baseline and at 12 months
AoV Vel (cm/s) will be measured using echocardiography.
At baseline and at 12 months
Change in aortic valve pressure gradient (AoV PG).
Time Frame: At baseline and at 12 months
AoV PG (mmHg) will be measured using echocardiography.
At baseline and at 12 months
Change in right ventricular end diastole (RVD).
Time Frame: At baseline and at 12 months
RVD (mm) will be measured using echocardiography.
At baseline and at 12 months
Change in pulmonary artery systolic pressure (PASP).
Time Frame: At baseline and at 12 months
PASP (mmHg) will be measured using echocardiography.
At baseline and at 12 months
Change in left ventricular fractional shortening (FS).
Time Frame: At baseline and at 12 months
Fractional shortening (%) will be measured using echocardiography.
At baseline and at 12 months
Change in depression II.
Time Frame: At baseline, at 6 months and at 12 months
Depression will be measured using the Patient Health Questionnaire (PHQ-9)), which is a self-administered instrument consisiting of 9 multiple-choice questions scored from 0 to 3. Higher total scores indicate higher depression severity.
At baseline, at 6 months and at 12 months
Change in depression I.
Time Frame: At baseline, at 6 months and at 12 months
Depression will be measured using the Beck Depression Inventory (BDI), which is a self-report questionnaire consisiting of 21 multiple-choice questions scored from 0 to 3. Higher total scores indicate more severe depressive symptoms.
At baseline, at 6 months and at 12 months
Change in depression and anxiety.
Time Frame: At baseline, at 6 months and at 12 months
Both depression and anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), which is a 14-item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater anxiety and depression.
At baseline, at 6 months and at 12 months
Change in mood.
Time Frame: At baseline, at 6 months and at 12 months
Mood will be measured using the Profile of Mood States (POMS) questionnaire, which uses a unipolar scale to rate the extent to which they are experiencing or have experienced 20 affect states in the past week using a 5-point scale (0 = not at all, 4 = extremely). Higher scores indicate greater negative mood.
At baseline, at 6 months and at 12 months
Change in anxiety.
Time Frame: At baseline, at 6 months and at 12 months
Anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which is an instrument that has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
At baseline, at 6 months and at 12 months
Change in physical self.
Time Frame: At baseline, at 6 months and at 12 months
Physical self will be measured using the Physical Self-Perception Profile (PSPP), which is an instrument with 30 questions comprising five 6-item subscales. Each item has a four-point structured-alternative format. Scores range from 6 to 24 on each subscale, with high scores representing positive perceptions. Half of the items are worded in the negative direction.
At baseline, at 6 months and at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in exercise-induced caloric expenditure
Time Frame: At baseline, at 6 months and at 12 months
Measured using a portable indirect calorimetry system
At baseline, at 6 months and at 12 months
Change in blood lactate concentration (BLa)
Time Frame: At baseline, at 6 months and at 12 months
BLa (mmol/L) concentration will be measured in a microphotometer with commercially available kits. Blood samples will be collected pre-, mid- and post-exercise session (single bout) at 3 min post-exercise
At baseline, at 6 months and at 12 months
Change in peak expiratory flow (PEF)
Time Frame: At baseline and at 12 months
PEF (l/s) will be measured using the maximum flow volume loop.
At baseline and at 12 months
Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75).
Time Frame: At baseline and at 12 months
FEF25-75 (l/s) will be measured using the maximum flow volume loop.
At baseline and at 12 months
Change in forced expiratory volume at 1 s (FEV1).
Time Frame: At baseline and at 12 months
FEV1 (l) will be measured using the maximum flow volume loop.
At baseline and at 12 months
Change in forced vital capacity (FVC).
Time Frame: At baseline and at 12 months
FVC (l) will be measured using the maximum flow volume loop.
At baseline and at 12 months
Change in the ratio of FEV1/FVC.
Time Frame: At baseline and at 12 months
FEV1/FVC (%) will be measured using the maximum flow volume loop.
At baseline and at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexios Batrakoulis, MSc, SmArT Lab, DPESS, University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DoIT II-UTH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Body Composition

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings