Sedentary BehaviorNCT06242899
Short Moderate-intensity Continuous Training on Sedentary Women's
A study testing Exercise in people with Sedentary Behavior, run by University of Valencia at 1 site in Spain.
Trial summary
Purpose: To determine the effects of three Short Moderate Intensity Continuous Training (SMICT) exercise programs with different durations, on functional capacity, resting heart rate (RHR) and physical activity enjoyment in sedentary women. Methods: A randomized clinical trial was performed. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 30 Dec 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Must be not regularly physically active for more than one month.
- Must be between 18 and 25 years of age.
- Must present a body mass index (BMI) between 18.5-24.9 kg/m2.
Who cannot join
- BMI≥25 kg/m2.
- Suffer from musculoskeletal or neurological diseases.
- Women with precarious medical conditions.
- Use of medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Short Moderate-intensity Continuous Training With Different Durations on Sedentary Women's Functional Capacity and Physical Activity Enjoyment. A Randomized Clinical Trial.
Purpose: To determine the effects of three Short Moderate Intensity Continuous Training (SMICT) exercise programs with different durations, on functional capacity, resting heart rate (RHR) and physical activity enjoyment in sedentary women.
Methods: A randomized clinical trial was performed. 45 sedentary women were randomly allocated to either a: i) 8-minutes short exercise group; ii) 10-minutes short exercise group; and iii) 15-minutes short exercise group. All three groups received a short exercise training program at moderate intensity for 3 sessions/week, over 3 weeks. Before and after the interventions, functional capacity was evaluated through the 6-minute walking test, and RHR with a pulse oximeter. Physical activity enjoyment was measured with the Physical Activity Enjoyment Scale after the intervention.
Read the detailed description
Sedentary lifestyles contribute to 3.2 million annual deaths globally, correlating with increased risks of cardiovascular diseases, obesity, and certain cancers. With women showing notably low physical activity rates, implementing tailored exercise interventions becomes crucial to enhance their activity levels and functionality, potentially mitigating risks associated with high resting heart rates linked to increased mortality, particularly from cardiovascular causes.
This was a randomized clinical trial involving 45 sedentary women split into three groups: 8-minute, 10-minute, and 15-minute exercise durations. All groups underwent moderate-intensity short exercise programs, differing only in duration. Functional capacity (measured by the 6-minute walking test) and resting heart rate (RHR) were assessed at baseline and after the 3-week intervention. Physical activity enjoyment was measured at the intervention's end.
- Conditions
- Sedentary Behavior
- Being tested
- Exercise
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise with a cycle ergometer in three phases:
- Warm-up: the exercise intensity was determined at 50-60% of HRmax obtained in the effort test, and lasted 2 minutes.
- Short exercise at moderate intensity for 8, 10 or 15 minutes according to group allocation. The exercise was cycling at 75% HRmax determined with an effort test.
- Cool down: the exercise intensity was determined at 50-60% of HRmax obtained in the effort test, and lasted 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 8-minutes short exercise group | Experimental | Participants performed an intervention for 3 sessions/week, over 3 weeks and a cycle ergometer was used. The workout regimen consisted of a structured warm-up lasting 2 minutes. The main exercise phase comprised an 8-minute cycling session performed at 75% of HRmax. Finally, a cool down phase lasting 2 minutes. Receives: Other: Exercise |
| 10-minutes short exercise group | Experimental | Participants performed an intervention for 3 sessions/week, over 3 weeks and a cycle ergometer was used. The workout regimen consisted of a structured warm-up lasting 2 minutes. The main exercise phase comprised an 10-minute cycling session performed at 75% of HRmax. Finally, a cool down phase lasting 2 minutes. Receives: Other: Exercise |
| 15-minutes short exercise group | Experimental | Participants performed an intervention for 3 sessions/week, over 3 weeks and a cycle ergometer was used. The workout regimen consisted of a structured warm-up lasting 2 minutes. The main exercise phase comprised an 15-minute cycling session performed at 75% of HRmax. Finally, a cool down phase lasting 2 minutes. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
6-minutes walking test (6MWT). This test consists of calculating the distance covered by the participant who was instructed to walk as quickly as possible along a 30-meter hallway without running for six minutes. Greater number of meters covered, better functional capacity.
Measured: Up to 3 weeks
Resting heart rate
Resting heart rate was measured with a pulse oximeter. The normal values for oxygen saturation (SpO2) in healthy adults measured by a pulse oximeter are 95% to 100%
Measured: Up to 3 weeks
Physical activity enjoyment
Physical activity enjoyment was measured with a modified version of the Physical Activity Enjoyment Scale (PACES). The scale is comprised of 17 items that are assessed using a 7-point bipolar scale. The final enjoyment score is calculated, and possible scores range from 17 (representing not enjoyable) to 68 (indicating neutral) to 119 (reflecting enjoyable). The higher score indicates greater enjoyment.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start10 Jan 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Marques-Sule, University of Valencia
- Investigators
- Elena Marqués Sulé, PhD, Principal investigator, Univeristy of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242899
- Sponsor's protocol ID
- AL-jouf University036
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Pines A. Sedentary women: sit less, live more! Climacteric. 2015;18(6):770-2. doi: 10.3109/13697137.2015.1038512. Epub 2015 Apr 14.
PubMed 25868822
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short Moderate-intensity Continuous Training With Different Durations on Sedentary Women's Functional Capacity and Physical Activity Enjoyment. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06242899
- Acronym / sponsor ID
- AL-jouf University036
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 5 Feb 2024 (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.
Purpose: To determine the effects of three Short Moderate Intensity Continuous Training (SMICT) exercise programs with different durations, on functional capacity, resting heart rate (RHR) and physical activity enjoyment in sedentary women.
Methods: A randomized clinical trial was performed. 45 sedentary women were randomly allocated to either a: i) 8-minutes short exercise group; ii) 10-minutes short exercise group; and iii) 15-minutes short exercise group. All three groups received a short exercise training program at moderate intensity for 3 sessions/week, over 3 weeks. Before and after the interventions, functional capacity was evaluated through the 6-minute walking test, and RHR with a pulse oximeter. Physical activity enjoyment was measured with the Physical Activity Enjoyment Scale after the intervention.
Detailed description
Sedentary lifestyles contribute to 3.2 million annual deaths globally, correlating with increased risks of cardiovascular diseases, obesity, and certain cancers. With women showing notably low physical activity rates, implementing tailored exercise interventions becomes crucial to enhance their activity levels and functionality, potentially mitigating risks associated with high resting heart rates linked to increased mortality, particularly from cardiovascular causes.
This was a randomized clinical trial involving 45 sedentary women split into three groups: 8-minute, 10-minute, and 15-minute exercise durations. All groups underwent moderate-intensity short exercise programs, differing only in duration. Functional capacity (measured by the 6-minute walking test) and resting heart rate (RHR) were assessed at baseline and after the 3-week intervention. Physical activity enjoyment was measured at the intervention's end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 8-minutes short exercise group | Experimental | Other: ExerciseParticipants performed an intervention for 3 sessions/week, over 3 weeks and a cycle ergometer was used. The workout regimen consisted of a structured warm-up lasting 2 minutes. The main exercise phase comprised an 8-minute cycling session performed at 75% of HRmax. Finally, a cool down phase lasting 2 minutes. |
| 10-minutes short exercise group | Experimental | Other: ExerciseParticipants performed an intervention for 3 sessions/week, over 3 weeks and a cycle ergometer was used. The workout regimen consisted of a structured warm-up lasting 2 minutes. The main exercise phase comprised an 10-minute cycling session performed at 75% of HRmax. Finally, a cool down phase lasting 2 minutes. |
| 15-minutes short exercise group | Experimental | Other: ExerciseParticipants performed an intervention for 3 sessions/week, over 3 weeks and a cycle ergometer was used. The workout regimen consisted of a structured warm-up lasting 2 minutes. The main exercise phase comprised an 15-minute cycling session performed at 75% of HRmax. Finally, a cool down phase lasting 2 minutes. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Must be not regularly physically active for more than one month.
- Must be between 18 and 25 years of age.
- Must present a body mass index (BMI) between 18.5-24.9 kg/m2.
Key exclusion criteria (4 listed)
- BMI≥25 kg/m2.
- Suffer from musculoskeletal or neurological diseases.
- Women with precarious medical conditions.
- Use of medications.
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 |
|---|---|---|
| ExerciseExercise with a cycle ergometer in three phases: * Warm-up: the exercise intensity was determined at 50-60% of HRmax obtained in the effort test, and lasted 2 minutes. * Short exercise at moderate intensity for 8, 10 or 15 minutes according to group allocation. The exercise was cycling at 75% HRmax determined with an effort test. * Cool down: the exercise intensity was determined at 50-60% of HRmax obtained in the effort test, and lasted 2 minutes. | Other | 10-minutes short exercise group, 15-minutes short exercise group, 8-minutes short exercise group |
Primary outcome
Functional capacity
Time frame: Up to 3 weeks
6-minutes walking test (6MWT). This test consists of calculating the distance covered by the participant who was instructed to walk as quickly as possible along a 30-meter hallway without running for six minutes. Greater number of meters covered, better functional capacity.
Resting heart rate
Time frame: Up to 3 weeks
Resting heart rate was measured with a pulse oximeter. The normal values for oxygen saturation (SpO2) in healthy adults measured by a pulse oximeter are 95% to 100%
Physical activity enjoyment
Time frame: Up to 3 weeks
Physical activity enjoyment was measured with a modified version of the Physical Activity Enjoyment Scale (PACES). The scale is comprised of 17 items that are assessed using a 7-point bipolar scale. The final enjoyment score is calculated, and possible scores range from 17 (representing not enjoyable) to 68 (indicating neutral) to 119 (reflecting enjoyable). The higher score indicates greater enjoyment.
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 5 Feb 2024.
- Background: PubMed 21694556Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Background: PubMed 25868822Pines A. Sedentary women: sit less, live more! Climacteric. 2015;18(6):770-2. doi: 10.3109/13697137.2015.1038512. Epub 2015 Apr 14.
- 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.
Elena Marqués Sulé, PhD principal investigator
Univeristy of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Sedentary Behavior, run by University of Valencia at 1 site in Spain.
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 4 inclusion and 4 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 5 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 Spain. 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?
Functional capacity (time frame: Up to 3 weeks). The study lists 3 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 NCT06242899, which also lists 2 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 5 Feb 2024.