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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06242899
Other study ID # AL-jouf University036
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date December 30, 2022

Study information

Verified date February 2024
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - BMI=25 kg/m2. - Suffer from musculoskeletal or neurological diseases. - Women with precarious medical conditions. - Use of medications.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
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.

Locations

Country Name City State
Spain University of Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

Pines A. Sedentary women: sit less, live more! Climacteric. 2015;18(6):770-2. doi: 10.3109/13697137.2015.1038512. Epub 2015 Apr 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 3 weeks
Primary 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% Up to 3 weeks
Primary 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. Up to 3 weeks
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