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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04693117
Other study ID # REC/Lhr/338
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2019
Est. completion date December 28, 2019

Study information

Verified date August 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 28, 2019
Est. primary completion date August 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria: - 30 obese (BMI = 30) and - Sedentary lifestyle subjects (sample size was calculated by using WHO sample size calculator) - Age 30-45 years and - Hypercholesteremia Exclusion Criteria: - hypertension, - diabetes, - cardiovascular diseases - systemic diseases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interval Training
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.

Locations

Country Name City State
Pakistan Riphah Rehabilitation Center Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Kiss O, Sydó N, Vargha P, Édes E, Merkely G, Sydó 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. — View Citation

Sobol NA, Hoffmann K, Frederiksen KS, Vogel A, Vestergaard K, Brændgaard H, Gottrup H, Lolk A, Wermuth L, Jakobsen S, Laugesen L, Gergelyffy R, Høgh 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. — View Citation

Sydó 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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