NCT04708873

Brief Summary

The obesity epidemic, predisposing to cardio-metabolic diseases, has increased two-folds over the last decade with a global alarming cost of obesity-associated illnesses, thus representing a grave peril for the survival of public health care systems. It is need of the time to develop evidence-based, time-efficient and cost-effective strategies to prevent and manage obesity. This study would compare the effects of 2 types of exercise regimes providing data on their beneficial effects on body composition and myocardial function along with reducing the central adiposity. This study may also be used as a novel intervention strategy for primary prevention of cardiovascular and metabolic diseases by modification of a major risk factor i.e. obesity in Pakistani population, consequently reducing the burden of morbidity and mortality from cardiometabolic diseases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

November 25, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 1, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

January 1, 2021

Last Update Submit

January 12, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percentage Body Fat

    Percentage body fat will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in forms of percentage (%).

    10 weeks

  • Visceral fat area

    Visceral fat area will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in form of centimeter square.

    10 weeks

Secondary Outcomes (4)

  • Left Ventricular Mass

    10 weeks

  • Left Ventricular Ejection Fraction

    10 weeks

  • Cholesterol/HDL ratio

    10 weeks

  • Fat free mass

    10 weeks

Study Arms (2)

High Intensity Interval Training Group

EXPERIMENTAL

Participants in this group will initially undergo continuous aerobic training to achieve a baseline fitness level, after which HIIT and resistance training will be employed. Warm-up period will be followed by 4 bouts of 4-minute interval treadmill running and stationary bike cycling at 80-95% of the measured HR reserve, interspersed with active recovery phase at 55-70% HRR. After this resistance exercises will be performed in a circuit fashion for strengthening the upper limbs, lower limbs and trunk. The session will be ended with a 5-7 minute cool-down period

Other: High intensity interval training

Moderate Intensity Continuous Training Group

ACTIVE COMPARATOR

Participants in this group will also initially undergo continuous aerobic training to achieve a baseline fitness level, after which the intensity will be increased to moderate continuous training achieving 55-70% of HRR. Every session will be preceded by appropriate warm-up and end with cool down.

Other: Moderate Intensity Continuous Training

Interventions

4x4 min intervals of high intensity treadmill running (80-95% of HRR, RPE 7-10 on Borg's category ratio scale of perceived exertion) interspersed with active recovery (slow jogging or fast walking at 50-70% HRR). HIIT-Resistance exercises 2 sessions per week, RPE 5 (hard) 6-8 RM, 1-3 sets of as many repetitions as possible in 60 seconds, active recovery 20-60 seconds b/w exercises,

High Intensity Interval Training Group

Moderate intensity continuous Aerobic exercises (Stationary cycling for 15-20 min followed by treadmill walking for 15-20 min) at 55-70% 55-70% of HRR, RPE 3-4 on Borg's category ratio scale of perceived exertion. The session will be preceded by 5-7 minute warm-up \& 7-10 min cool-down.

Moderate Intensity Continuous Training Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals categorized as Overweight (BMI 23.0 to 24.9) and Obese-Class I (BMI 25.0 to 29.9).
  • Both males \& females willing to participate in the study.
  • Otherwise healthy young adults aged 18-35 and middle-aged adults (36-55 years).
  • No participation in an exercise or PA program during the last 6 months prior to the study.
  • Participants able to complete 6-minute walk test as sub-maximal evaluation test without provoking sign and symptoms.

You may not qualify if:

  • Any diagnosed neuromuscular, cardiac, renal, lung, liver disease.
  • Individuals with implantable electrical devices such as pacemakers.
  • Any physical or psychological dysfunction that hinders participation in the study.
  • Individuals already participating in any structured program for weight loss including dietary interventions or usage of nutritional supplements.
  • Individuals unable to complete 6 minute walk test due to any reason (dyspnea, fatigue, chest pain etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
It will be a single blinded study. Only the participants will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated to Interventional Group A (High intensity aerobic \& resistance interval training) or Interventional Group B/ Control Group (Moderate intesity continuous training) for the whole duration of the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2021

First Posted

January 14, 2021

Study Start

November 25, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations