- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04693117
Functional Impact of Interval Training on Muscle Mass and Strength in Obese Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Study Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric measurement (Body Mass Index)
Time Frame: 3 months
|
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
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Functional capacity
Time Frame: 3 Months
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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
|
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Anthropometric measurement (Lean body mass)
Time Frame: 3 months
|
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.
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3 months
|
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Functional Capacity
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/338
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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