Home Based or Traditional Class HIIT in Overweight Women.
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMarch 16, 2021
March 1, 2021
4 months
February 24, 2021
March 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Secondary Outcomes (3)
Change from Baseline, between and within groups comparison, in Quality of Life
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in Eating Behaviour
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in Enjoyment
0,4,8,16,32 weeks
Study Arms (3)
Control
NO INTERVENTIONNo intervention. The control group will maintain their normal physical and dietary activity.
Homebased HIIT
EXPERIMENTAL16-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
EXPERIMENTAL16-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- female individuals aged between 25 and 50 years old, at the time of selection;
- have a BMI equal to or greater than 25kg/m2;
- have the ZOOM application (San Jose, USA) and a 2x2m2 space at home for the practice of HIIT;
- who present, in their own form, authorized consent to participate in the referred study. Only one person per household will be allowed to be included.
You may not qualify if:
- having any health problem and/or condition that limit the implementation of an HIIT program;
- taking medication that influences the variables to be studied;
- being involved in any type of exercise intervention/program;
- being in pre-menopause or menopause period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Évoralead
- Raimundo, Armando, PhDcollaborator
- Bravo, Jorge, PhDcollaborator
- Mota, Jorge, PhD, University of Portocollaborator
Related Publications (29)
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PMID: 25785929BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jorge Mota, PhD
Universidade do Porto
- STUDY DIRECTOR
Armando Raimundo, PhD
Universidade de Evora
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participants will be randomized and alllocated in one of the three groups (control or experimental HIIT Homebased or experimental HIIT traditional)
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctoral Student
Study Record Dates
First Submitted
February 24, 2021
First Posted
March 15, 2021
Study Start
December 1, 2021
Primary Completion
April 1, 2022
Study Completion
September 1, 2022
Last Updated
March 16, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Starting 6 months after publication
Yes. We will publish the protocol and study results.