NCT06609954

Brief Summary

Obesity is a global health concern associated with an increased risk of cardio-metabolic diseases and reduced overall health. Exercise is a proven modality for managing obesity, with current focus of researches on identifying more time-efficient modes of exercise training. REHIT and HIIT have proven benefits but comparative effects of REHIT and HIIT in overweight and obese adults is yet to be determined. Hence the objective of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus high intensity interval training (HIIT) on anthropometric measures (weight, waist circumference, hip circumference, waist-to-hip ratio), CUN-BAE adiposity index and cardiorespiratory fitness in overweight and obese adults.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

June 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

September 24, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

September 20, 2024

Last Update Submit

September 20, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Waist circumference

    Will be measured using a cloth tape measure. Waist circumference will be measured at the level of the smallest circumference above the umbilicus and below the xiphoid appendix.

    6 weeks

  • Hip Circumference:

    Measure at the widest point of the hips, with feet together

    6 weeks

  • Waist-to-hip Ratio:

    To determine the waist-to-hip ratio, divide the WC by the HC

    6 weeks

  • Cardiorespiratory fitness

    Cardiorespiratory Fitness will be assessed via Queens College step test.

    6 weeks

  • Adiposity index

    Evaluation will be done using CUN-BAE INDEX (Clínica Universidad de Navarra-Body Adiposity Estimator)

    6 weeks

Study Arms (2)

Reduced Exertion High intensity Training (REHIT) Group

EXPERIMENTAL

Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform training sessions on a cycle ergometer.A 3-minute cool-down period will conclude each session. Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration.

Other: Reduced Exertion High Intensity Training (REHIT)

High Intensity Interval Training (HIIT)

EXPERIMENTAL

Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform a warm up of 5 min, then 4 bouts of 4 min of HIIT will be performed at 80%-95% of HRR separated by 3-min active recovery periods of moderate intensity cycling at 60%-70% of the HRR followed by 5 min cool down exercises. Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration.

Other: High Intensity Interval Training (HIIT)

Interventions

Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform training sessions on a cycle ergometer. Each session will consist of a 3-minute warm-up period followed by two 20-second all-out sprints interspersed with 3 minutes of slow pedaling for recovery. Total of 18 sessions of REHIT will be performed thrice a week on alternate days by the participants for consecutive 6 weeks.

Reduced Exertion High intensity Training (REHIT) Group

Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration. Week 1 will be baseline fitness level and familiarization week. Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform a warm up of 5 min, then 4 bouts of 4 min of HIIT will be performed at 80%-95% of HRR separated by 3-min active recovery periods of moderate intensity cycling at 60%-70% of the HRR followed by 5 min cool down exercises. Pre and post session vitals will be noted. Total of 18 sessions of either HIIT will be performed thrice a week on alternate days by the participants for consecutive 6 weeks.

High Intensity Interval Training (HIIT)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female adults aged 18-45 years
  • Overweight individuals with BMI ≥ 23kg/m²- 24.9kg/m²
  • Obese individuals with BMI ≥ 25kg/m²

You may not qualify if:

  • Individuals with any diagnosed cardiovascular, metabolic or pulmonary disease
  • Current neurological or musculoskeletal conditions which limit participation in the study
  • Any active infections
  • Those with any contraindication to exercise testing or training.
  • Currently following any dietary restriction plans for weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single-blinding
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group(interventional group) will be given Reduced Exertion High Intensity Training (REHIT) and the other group (control group) will be given High intensity Interval Training (HIIT).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

June 10, 2024

Primary Completion

December 10, 2024

Study Completion

December 30, 2024

Last Updated

September 24, 2024

Record last verified: 2024-08

Locations