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| Name | Class |
|---|---|
| Raimundo, Armando, PhD | UNKNOWN |
| Bravo, Jorge, PhD | UNKNOWN |
| Universidade do Porto | OTHER |
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The present protocol aims to evaluate the effect of two different 16-week High-intensity interval training (HIIT) programs on daily physical activity, body composition, cardiorespiratory fitness, eating behaviour, enjoyment and quality of life in overweight women. Methods: Ninety overweight women (25 - 50 years old) with a body mass index ≥ 25 kg/m2 will be randomly assigned to three groups of 30 participants: a remote home-based HIIT intervention group; a traditional HIIT intervention group; and a non-exercise control group. Both intervention groups will undergo a 16-week progressive HIIT program following the Tabata method. Participants will be assessed at baseline, 4th, 8th, and after 16-week for physical activity, body composition, cardiorespiratory fitness, eating behaviour, enjoyment and quality of life. The study will have a 16-week follow-up post intervention. Results: The participant's enrolment will begin in December 2021, and investigators will anticipate the study completion by the mid of 2022. Conclusions: The HIIT programs might have beneficial effects on daily physical activity, body composition, cardiorespiratory fitness and overall quality of life in overweight women. Moreover, it might be a more enjoyable form of exercise, once it is performed faster than other exercise forms. As a beneficial side effect, these healthy behaviours might have a favourable impact on women's eating behaviours. This study results are expected to add health and well-being professionals' evidence-based knowledge to create strategies and design home-based exercise interventions.
Methods Trial design: The study will be a 3-arm Randomized Controlled Trial, in which a similar number of participants will be assigned to three groups: a supervised remote home-based HIIT intervention group (Home-HITT), or a presential a supervised traditional HIIT intervention group (Traditional-HIIT), and a non-exercise control group (CG). The study will have a 32-week duration and will be carried out in Portugal. This RCT will be "single-blind".
This study has been designed according to CONSORT statement for clinical trials. This RCT will apply the "intention-to-treat principle".
Dose rationale: The CG participants will maintain their usual physical and dietary activity. Nevertheless, after the 16-week intervention, participants selected to the CG will have the chance to receive the same 16-week HIIT program. Both interventions will consist of a 16-week exercise program with HIIT with a frequency of 3 days/week. The Home-HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application, while the Traditional-HIIT group participants will attend HIIT workout sessions supervised in person by the same instructor. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT training and 5 minutes' cool-down. The intervention will have a type of HIIT program called the Tabata method once it can be performed in home-based programs. Tabata training method has been defined as a HIIT with submaximal effort performed at 80-95% of maximal heart rate.
Tabata method uses eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. It seems that this method is demanding for ordinary adults so it will have four stages of physical adaptation.
Before each session, all participants in the intervention groups will receive a class reminder through a short message service (SMS). After each session, all participants will also receive an SMS with positive reinforcement about their exercise session participation. In order to compensate for possible absences, extra classes will be given. The 16 weeks intervention period was chosen because evidence shows that this period is sufficient to evidence changes in PA levels. Guidelines suggest the need to accumulate 75 min/week of vigorous-intensity PA. Despite the guidelines, this exercise protocol will be characterized by progression in both exercise intensity and volume because the investigators will be handling sedentary and overweight women.
The present study will have a follow-up period of 16 weeks. During this period, it is necessary to verify the study variables' evolution.
Selection and Withdrawal of Subjects: Participants in this study will be volunteers recruited through Health Centers Portimão, Lagoa and Lagos (Algarve, Portugal) and through promotional flyers placed in region´s local councils. All the participants will be informed of the procedures of the study before signing the informed consent form.
Subject Withdrawal: Individuals will be removed from the study when the following situations are verified: i) medical indication; ii) prolonged illness during the study or injury incapacitating to continue the study; iii) show willingness to leave the study. Participants may be replaced if the withdrawal happens before the intervention starts.
Discontinuation: The study should be interrupted if it is found that the application of the HIIT exercise program is at the origin of the participants physical and/or psychological problems. There will also be an interruption of the study if it is found that the participant initiated a physical exercise program parallel to the study.
Sample size Determination: To determine a priori the sample size, investigators used G*Power (version 3.1.9.7). The sample size was determined by the study's primary objective (effect of the intervention on PA, body composition and cardiovascular health). Based on a large effect size of 0.80 (Cohen's f), performing a sample size calculation for repeated measures analysis of variance with an expectable correlation of 0.50 between measurements, alfa of 0.05 and 85% of power, a total sample size of 60 women will be needed.
Once the investigators have two experimental groups, the aim is to have 90 women in this study.
Statistical Analysis SPSS (StatisticalPackage for the SocialSciences) software, version 27.0, IBM Windows will be used.
Regarding the procedures for sample distribution characterization's, the mean, standard deviation and amplitude of the distribution (min. value and max. value) will be determined. To determine data normality, the investigators will use the Kolmogorov-Smirnov analysis. Parametric statistics will be applied if data is normally distributed. One-way ANOVA will be used for comparisons of the three groups on all outcome's variables. To determine the relation between the independent measures, the investigators will use a two-way ANOVA. If there are significant differences between the different groups, the Bonferroni Post-hoc test will determine significance levels. In this study, the investigators will use a p-value of 0.05.
Randomization: In order to minimize selection bias, stratified randomization will be carried out when allocating individuals to the experimental and control groups, thus maintaining identical characteristics in both groups This stratification will be carried out based on age, sex and ethnicity.
Instruments: For the present study, participants will be evaluated before the intervention in the 4th ,8th and 16th week of the intervention. After that, participants will be evaluated in the 32nd week for follow-up to analyse the possible effect of detraining. Assessments will be performed through the following instruments:
Timing: According to the inclusion/exclusion criteria mentioned, the participants will be assessed to be eligible to participate in the study. In December 2021, participants will be randomized and allocated in three different groups (CG, Home HIIT and Class HIIT). The intervention will begin in December 2021 and end in September 2022. The close-out of the study will be in September.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No intervention. The control group will maintain their normal physical and dietary activity. | |
| Homebased HIIT | Experimental | 16-week exercise program with HIIT with a frequency of 3 days/week. The Homebased HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application. This group will have 16 week follow-up. |
|
| Traditional HIIT | Experimental | 16-week exercise program with HIIT with a frequency of 3 days/week. The Traditional-HIIT group participants will attend presential HIIT workout sessions supervised. This group will have 16 week follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home based HIIT | Other | Intervention will consist in a 16-week exercise program with HIIT with a frequency of 3 days/week. The Home-HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT (stages of physical adaptation every 4 weeks) training and 5 minutes' cool-down. Tabata method will be used with eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. The intervention will have four stages of physical adaptation. This group will have a follow-up period of 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline, between and within groups comparison, in Physical activity. | Objectively measured daily physical activity will be assessed through accelerometers. | 0,4,8,16,32 weeks |
| Change from Baseline, between and within groups comparison, in Cardiorespiratory fitness. | To assess VO2max the Chester Step Test will be used. | 0,4,8,16,32 weeks |
| Change from Baseline, between and within groups comparison, in percentage of fat mass. | It will be assessed % fat mass with a bioimpedance weighing machine electric model Tanita BC601. | 0,4,8,16,32 weeks |
| Change from Baseline, between and within groups comparison, in bone mass. | It will be assessed bone mass with a bioimpedance weighing machine electric model Tanita BC601. The bone mass will be reported in kilograms. | 0,4,8,16,32 weeks |
| Change from Baseline, between and within groups comparison, in muscle mass. | It will be assessed muscle mass with a bioimpedance weighing machine electric model Tanita BC601. The muscle mass will be reported in kilograms. | 0,4,8,16,32 weeks |
| Change from Baseline, between and within groups comparison, in body mass index (BMI). | Weight and height will be measured to the nearest 0.1kg and 0.1cm correspondingly. For BMI, weight in kilograms will be divided by height in squared meters (kg/m2). | 0,4,8,16,32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline, between and within groups comparison, in Quality of Life | To assess the quality of life it will be used the Portuguese version of the SF-36 Questionnaire | 0,4,8,16,32 weeks |
| Change from Baseline, between and within groups comparison, in Eating Behaviour |
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Inclusion Criteria:
Exclusion Criteria:
Overweight women between 25 and 50 years old.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joao Carmo, M.Sc. | Contact | 00351 965808413 | joaolfcarmo@gmail.com | |
| Jorge Bravo, PhD | Contact | jorgebravo@uevora.pt |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Mota, PhD | Universidade do Porto | Study Director |
| Armando Raimundo, PhD | Universidade de Evora | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20625115 | Background | Artinian NT, Fletcher GF, Mozaffarian D, Kris-Etherton P, Van Horn L, Lichtenstein AH, Kumanyika S, Kraus WE, Fleg JL, Redeker NS, Meininger JC, Banks J, Stuart-Shor EM, Fletcher BJ, Miller TD, Hughes S, Braun LT, Kopin LA, Berra K, Hayman LL, Ewing LJ, Ades PA, Durstine JL, Houston-Miller N, Burke LE; American Heart Association Prevention Committee of the Council on Cardiovascular Nursing. Interventions to promote physical activity and dietary lifestyle changes for cardiovascular risk factor reduction in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 27;122(4):406-41. doi: 10.1161/CIR.0b013e3181e8edf1. Epub 2010 Jul 12. No abstract available. | |
| 20032779 |
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Yes. We will publish the protocol and study results.
Starting 6 months after publication
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2021 | Mar 3, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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3 arm parallel groups
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The participants will be randomized and alllocated in one of the three groups (control or experimental HIIT Homebased or experimental HIIT traditional)
|
| Traditional HIIT | Other | Intervention will consist in a 16-week exercise program with HIIT with a frequency of 3 days/week. The Traditional HIIT group participants will attend a group HIIT workout sessions supervised by a specialised instructor in a sport facility. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT (stages of physical adaptation every 4 weeks) training and 5 minutes' cool-down. Tabata method will be used with eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. The intervention will have four stages of physical adaptation. This group will have a follow-up period of 16 weeks. |
|
The eating behaviour will be assessed through the Portuguese version of the Three-Factor Eating Questionnaire - R21 |
| 0,4,8,16,32 weeks |
| Change from Baseline, between and within groups comparison, in Enjoyment | To measure the enjoyment it will use Portuguese version of the the PACES scale. This is a 8-item scale. Each item has a 7-point Likert scale (1= unpleasurable; 7= pleasurable). | 0,4,8,16,32 weeks |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |