NCT07276308

Brief Summary

This study aims to explore how stress-related hormones and psychological traits influence people's feelings and perceptions during a short and intense form of exercise called low-volume high-intensity interval exercise (Lv-HIIE). Adults with overweight or obesity participated in a supervised 10-week cycling program consisting of repeated one-minute high-intensity efforts separated by short recovery periods. The research examines how psychophysiological stress markers (such as cortisol and ACTH), cognitive traits (such as goal orientation and hardiness), and perceptual responses (such as exertion, mood, and enjoyment) change over time. Findings from this study may help develop exercise programs that are more enjoyable, sustainable, and personalized for individuals with higher body-mass categories.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 14, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

ExercisePsychophysiological StressCognitive traitsAffective ResponsesHigh-Intensity Interval ExercisePerceptual Responses

Outcome Measures

Primary Outcomes (13)

  • Outcome Measure: Height

    Standing height will be measured using a stadiometer with participants barefoot and standing in the anatomical position. The value used for analysis will be the height recorded at baseline (Session 1).Unit of Measure: centimeters (cm)

    Baseline only (Session 1)

  • Outcome Measure: Body Weight

    Body weight will be measured using a calibrated digital scale with participants wearing light clothing and no shoes. The value used for analysis will be the body weight recorded at baseline (Session 1).Unit of Measure: kilograms (kg)

    Session 1 (Week 0), Session 15 (Week 5), Session 30 (Week 10)

  • Outcome Measure: Body Mass Index (BMI)

    BMI will be calculated using height and weight measured at baseline, using the formula BMI = weight (kg) / height (m²). The final reported value will be the BMI calculated at Session 1.Unit of Measure: kg/m²

    Session 1 (Week 0), Session 15 (Week 5), Session 30 (Week 10)

  • Change in Affective Valence During Low-Volume High-Intensity Interval Exercise

    Affective valence is assessed using the Feeling Scale (range -5 to +5) during each low-volume high-intensity interval exercise (Lv-HIIE) session, which consists of 6-10 cycles of 60 s shuttle running and 75 s active recovery. Affective valence is measured 5 minutes before exercise, 20 seconds before the end of warm-up, immediately after each 60-second work interval, and after cool-down during Sessions 1, 15, and 30. The reported value will be the mean change in Feeling Scale score from Session 1 to Session 30, with Session 15 serving as a mid-intervention reference time point.Feeling Scale score (-5 to +5)

    Measured at every training session (Sessions 1-30) over 10 weeks; primary analysis compares Sessions 1, 15, and 30

  • Change in Felt Arousal During Low-Volume High-Intensity Interval Exercise

    Felt arousal is assessed using the Felt Arousal Scale (range 1 to 6) during Lv-HIIE sessions (6-10 cycles of 60 s work + 75 s active recovery). Felt arousal is measured 5 minutes before exercise, 20 seconds before the end of warm-up, immediately after each 60-second work interval, and after cool-down during Sessions 1, 15, and 30. The reported value will be the mean change in Felt Arousal Scale score from Session 1 to Session 30, with Session 15 as a mid-intervention reference.Felt Arousal Scale score (1-6)

    Measured at every training session (Sessions 1-30) over 10 weeks; primary analysis compares Sessions 1, 15, and 30

  • Change in Rating of Perceived Exertion During Low-Volume High-Intensity Interval Exercise

    Rating of perceived exertion (RPE) is measured using the Borg 6-20 scale during Lv-HIIE sessions (6-10 cycles of 60 s work + 75 s active recovery). RPE is recorded 5 minutes before exercise, 20 seconds before the end of warm-up, immediately after each 60-second work interval, and after cool-down during Sessions 1, 15, and 30. The reported value will be the mean change in RPE from Session 1 to Session 30, with Session 15 as a mid-intervention reference point.Borg RPE score (6-20)

    Measured at every training session (Sessions 1-30) over 10 weeks; primary analysis compares Sessions 1, 15, and 30

  • Change in Perceived Recovery During Low-Volume High-Intensity Interval Exercise

    Perceived recovery is assessed using the Perceived Recovery Scale (range 0 to 10) during Lv-HIIE sessions. It is measured immediately after each 75-second active recovery interval in every cycle during Sessions 1, 15, and 30. The reported value will be the mean change in Perceived Recovery Scale score from Session 1 to Session 30, with Session 15 as a mid-intervention reference.Perceived Recovery Scale score (0-10)

    Measured at every training session (Sessions 1-30) over 10 weeks; primary analysis compares Sessions 1, 15, and 30

  • Change in Exercise Enjoyment During Low-Volume High-Intensity Interval Exercise

    Exercise enjoyment is assessed using a validated enjoyment scale (range 1 to 7) at the end of the Lv-HIIE session. Enjoyment is measured once at the end of Sessions 1, 15, and 30. The reported value will be the change in enjoyment score from Session 1 to Session 30, with Session 15 as a mid-intervention reference.Enjoyment scale score (total 126 scores)

    Measured at the end of Sessions 1, 15, and 30 over 10 weeks

  • Change in Heart Rate During Low-Volume High-Intensity Interval Exercise

    Heart rate is measured continuously and summarized at specific time points (5 minutes before exercise, 20 seconds before the end of warm-up, immediately after each 60-second work interval, and after cool-down) during Lv-HIIE sessions (6-10 cycles of 60 s work + 75 s active recovery). Heart rate is recorded during Sessions 1, 15, and 30. The reported value will be the mean change in heart rate (beats per minute) from Session 1 to Session 30, with Session 15 as a mid-intervention reference.Beats per minute (bpm)

    Measured at every training session (Sessions 1-30) over 10 weeks; primary analysis compares Sessions 1, 15, and 30

  • Change in Heart Rate Recovery During Low-Volume High-Intensity Interval Exercise

    Heart rate recovery is assessed as heart rate measured immediately after each 75-second active recovery interval during Lv-HIIE sessions. Heart rate recovery is recorded for all cycles in Sessions 1, 15, and 30. The reported value will be the mean change in heart rate recovery (beats per minute during recovery periods) from Session 1 to Session 30, with Session 15 as a mid-intervention reference.Beats per minute (bpm)

    Measured at every training session (Sessions 1-30) over 10 weeks; primary analysis compares Sessions 1, 15, and 30

  • Psychophysiological Stress (Blood Biomarkers)

    Psychophysiological stress will be assessed using venous blood biomarkers. Blood samples will be collected at three predefined assessment days during the 10-week intervention: Day 1 (Week 1, baseline), Day 15 (Week 5), and Day 30 (Week 10, final assessment). At each assessment day, venous blood will be drawn at three standardized time points: Immediately before exercise (pre-exercise) Immediately after exercise (0 minutes post-exercise) 30 minutes post-exercise This results in nine total blood draws per participant. Biomarkers include cortisol, ACTH, and related stress markers. Changes will be compared across these assessment days.Concentration (pg/mL or ng/mL)

    Day 1 (Week 1, baseline), Day 15 (Week 5), and Day 30 (Week 10, final assessment), with samples collected pre-exercise, immediately post-exercise, and 30 minutes post-exercise

  • Goal Orientation in Exercise Measure (GOEM) Total Score

    Goal orientation will be assessed using the Goal Orientation in Exercise Measure (GOEM), a validated 10-item questionnaire scored on a 5-point Likert scale (1-5). Item scores are summed to produce a total GOEM score ranging from 0 to 50. The questionnaire is completed once at baseline, before the first training session, to characterize individual differences in goal-orientation tendencies that may influence perceptual and physiological responses during the intervention. The reported value will be the total GOEM score.Score range 0-50

    Baseline (Day 1, before the first training session)

  • Connor-Davidson Resilience Scale (CDRS) Total Score

    Psychological resilience will be assessed using the Connor-Davidson Resilience Scale (CDRS), a validated resilience questionnaire producing a total score ranging from 0 to 100. The scale is administered once at baseline, prior to the first training session, to evaluate individual differences in resilience traits that may influence perceptual and physiological responses during the intervention. The reported value will be the total CDRS score.Score range 0-100

    Baseline (Day 1, before the first training session)

Study Arms (1)

Low-Volume High-Intensity Interval Exercise (Lv-HIIE)

EXPERIMENTAL

Participants will perform a low-volume high-intensity interval exercise (Lv-HIIE) program consisting of 6-10 cycling intervals at 90% of maximal aerobic speed, interspersed with 75-second active recovery periods. The intervention will be conducted three times per week for 10 weeks under supervised laboratory conditions. Each session will include standardized warm-up and cool-down phases. The study aims to evaluate psychophysiological stress, cognitive markers, and perceptual responses across repeated exercise sessions in overweight-to-obese adults.

Behavioral: Low-Volume High-Intensity Interval Exercise (Lv-HIIE)

Interventions

The intervention consists of a supervised low-volume high-intensity interval exercise (Lv-HIIE) program performed on a cycle ergometer. Each session includes 6-10 intervals of 1 minute at 90% of maximal aerobic speed, interspersed with 75-second active recovery periods. Participants will train three times per week for 10 weeks under laboratory supervision. Each session begins with a standardized 5-minute warm-up and ends with a 5-minute cool-down. The program is designed to investigate changes in psychophysiological stress (ACTH, cortisol), cognitive markers (goal orientation, hardiness), and perceptual responses (affective valence, perceived exertion, enjoyment) across repeated exercise exposures in overweight-to-obese adults.

Also known as: Lv-HIIE Training, Low-Volume HIIE, High-Intensity Interval Exercise Program
Low-Volume High-Intensity Interval Exercise (Lv-HIIE)

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female between the ages of 20-35 years old
  • BMI of 23 kg.m² to 30 kg.m2
  • Medically fit to exercise.
  • Physically inactive individuals (do not achieve 150 minutes of moderate-intensity exercise/PA for a week).

You may not qualify if:

  • smokers.
  • free from any metabolic diseases such as hypertension, dyslipidaemia, and hyperglycaemia.
  • not using any medication or substance known to influence cardiorespiratory or metabolic responses to exercise
  • previously participated in a specific training program within the past 6 months before the exercise interventions.
  • contraindications to exercise based on the Physical Activity Readiness Questionnaire (PAR-Q) such as musculoskeletal injuries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Sains Malaysia, Health Campus, Complex sports center

Kota Bharu, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

OverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (PhD Candidate)

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 11, 2025

Study Start

March 1, 2023

Primary Completion

August 20, 2023

Study Completion

September 1, 2023

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations