NCT04693117

Brief Summary

The primary objective was to investigate the effectiveness of interval training and to evaluate the best available method for measuring body composition and functional capacity. Thirty obese subjects consecutively voluntarily participated in the current study. They ranked sedentary according to their level of activity (≥ 30-minute moderate physical activity 3days/wk). The training sessions were divided into the warm-up phase, training phase and a cool-down phase. The training programs were completed 3days/week for 12 weeks. Body composition was calculated by skinfold thickness method and bio-impedance before and after training. Similarly, aerobic capacities were measured by lactate threshold testing and by Astrand submaximal testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

December 30, 2020

Last Update Submit

August 27, 2021

Conditions

ObeseMuscle StrengthInterval Training

Keywords

ObesityBody compositionExercise testing

Outcome Measures

Primary Outcomes (4)

  • Anthropometric measurement (Body Mass Index)

    Body Mass Index: BMI Weight Status Below 18.5 Underweight 18.5 - 24.9 Normal or Healthy Weight 25.0 - 29.9 Overweight 30.0 and Above Obese

    3 months

  • Functional capacity

    The functional capacity was assessed by lactate threshold level and by Astrand submaximal testing by using standardized protocol. Lactate inflection point (LIP), is the exercise intensity at which the blood concentration of lactate and/or lactic acid begins to increase rapidly. It is often expressed as 85% of maximum heart rate or 75% of maximum oxygen intake.

    3 Months

  • Anthropometric measurement (Lean body mass)

    Lean body mass:Lean body mass is calculated as the difference between total body weight and body fat weight, or more simply, the weight of everything except the fat. The range of lean body mass considered to be healthy is around 70% - 90% with women being towards the lower end of the range and men higher.

    3 months

  • Functional Capacity

    The functional capacity was assessed by Astrand submaximal testing by using standardized protocol. The Astrand Test is a submaximal cycle ergometer aerobic fitness test best suited in rehabilitation and health purposes. description: Athletes pedal on a cycle ergometer at a constant workload for 7 minutes. Heart rate is measured every minute, and the steady state heart rate is determined.

    3 months

Study Arms (1)

Study Group

EXPERIMENTAL

Participants were voluntarily participated by non-probability consecutive sampling. It was a one group study with a limitation of non-randomization. The interventional group had performed interval training for 12 weeks, 3 days/week (figure 1). They sedentary conferring to activity level (≥ 30-minute, 3 days/weeks, moderate-intensity physical activity). They were not participated in any interval training program before participating in the study from six months. Written consent was taken after demonstration of the purpose, procedure, and related pros and cons. They were instructed to participate regularly in interval training.

Other: Interval Training

Interventions

Interval TrainingOTHER

All individual of interventional group participated in an interval training program, which comprised of 3 days/week for twelve weeks. A booklet was given to each participant containing instructions and guideline about interval training. The interval training program was introduced as prescribed previously.17 After the workout, a cool down period of 5 minutes was given during which they perform paddling with low speed. All training program was supervised by a qualified physical therapist.

Study Group

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • obese (BMI ≥ 30) and
  • Sedentary lifestyle subjects (sample size was calculated by using WHO sample size calculator)
  • Age 30-45 years and
  • Hypercholesteremia

You may not qualify if:

  • hypertension,
  • diabetes,
  • cardiovascular diseases
  • systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • Sydo N, Abdelmoneim SS, Mulvagh SL, Merkely B, Gulati M, Allison TG. Relationship between exercise heart rate and age in men vs women. Mayo Clin Proc. 2014 Dec;89(12):1664-72. doi: 10.1016/j.mayocp.2014.08.018. Epub 2014 Oct 29.

    PMID: 25441400BACKGROUND

  • Al-Shawwa B, Al-Huniti N, Titus G, Abu-Hasan M. Hypercholesterolemia is a potential risk factor for asthma. J Asthma. 2006 Apr;43(3):231-3. doi: 10.1080/02770900600567056.

    PMID: 16754527BACKGROUND

  • Sobol NA, Hoffmann K, Frederiksen KS, Vogel A, Vestergaard K, Braendgaard H, Gottrup H, Lolk A, Wermuth L, Jakobsen S, Laugesen L, Gergelyffy R, Hogh P, Bjerregaard E, Siersma V, Andersen BB, Johannsen P, Waldemar G, Hasselbalch SG, Beyer N. Effect of aerobic exercise on physical performance in patients with Alzheimer's disease. Alzheimers Dement. 2016 Dec;12(12):1207-1215. doi: 10.1016/j.jalz.2016.05.004. Epub 2016 Jun 23.

    PMID: 27344641BACKGROUND

  • Faude O, Kindermann W, Meyer T. Lactate threshold concepts: how valid are they? Sports Med. 2009;39(6):469-90. doi: 10.2165/00007256-200939060-00003.

    PMID: 19453206BACKGROUND

  • Donges CE, Duffield R, Drinkwater EJ. Effects of resistance or aerobic exercise training on interleukin-6, C-reactive protein, and body composition. Med Sci Sports Exerc. 2010 Feb;42(2):304-13. doi: 10.1249/MSS.0b013e3181b117ca.

    PMID: 20083961BACKGROUND

  • Kiss O, Sydo N, Vargha P, Edes E, Merkely G, Sydo T, Merkely B. Prevalence of physiological and pathological electrocardiographic findings in Hungarian athletes. Acta Physiol Hung. 2015 Jun;102(2):228-37. doi: 10.1556/036.102.2015.2.13.

    PMID: 26100312BACKGROUND

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

Study Officials

  • Maryam Shabbir, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2020

First Posted

January 5, 2021

Study Start

June 5, 2019

Primary Completion

August 28, 2019

Study Completion

December 28, 2019

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)