NCT06242899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 10, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

January 23, 2024

Last Update Submit

February 1, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

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.

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.

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.

Other: Exercise

Interventions

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.

10-minutes short exercise group15-minutes short exercise group8-minutes short exercise group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSedentary women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • BMI≥25 kg/m2.
  • Suffer from musculoskeletal or neurological diseases.
  • Women with precarious medical conditions.
  • Use of medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related 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.

    PMID: 21694556BACKGROUND
  • Pines A. Sedentary women: sit less, live more! Climacteric. 2015;18(6):770-2. doi: 10.3109/13697137.2015.1038512. Epub 2015 Apr 14.

    PMID: 25868822BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elena Marqués Sulé, PhD

    Univeristy of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 5, 2024

Study Start

January 10, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations