ObeseNCT04693117
Functional Impact of Interval Training on Muscle Mass and Strength in Obese Adults
A study testing Interval Training in people with Obese and Muscle Strength, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Muscle Strength, Interval Training
- What is being tested?
- Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jun 2019to 28 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30 obese (BMI ≥ 30) and
- Sedentary lifestyle subjects (sample size was calculated by using WHO sample size calculator)
- Age 30-45 years and
- Hypercholesteremia
Who cannot join
- hypertension,
- diabetes,
- cardiovascular diseases
- systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obese, Muscle Strength, Interval Training
- Being tested
- Interval Training
- Keywords
- Obesity, Body composition, Exercise testing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start5 Jun 2019
- Primary completion28 Aug 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shabbir, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693117
- Sponsor's protocol ID
- REC/Lhr/338
- Status last verified
- Aug 2021
- First submitted
- 30 Dec 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25441400Al-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.
PubMed 16754527Sobol 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.
PubMed 27344641Faude 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.
PubMed 19453206Donges 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.
PubMed 20083961Kiss 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.
PubMed 26100312
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Impact of Interval Training on Muscle Mass and Strength in Obese Adults
- ClinicalTrials.gov ID
- NCT04693117
- Acronym / sponsor ID
- REC/Lhr/338
- Conditions
- Obese, Muscle Strength, Interval Training
- Keywords
- Obesity, Body composition, Exercise testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Interval TrainingParticipants 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. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 30 obese (BMI ≥ 30) and
- Sedentary lifestyle subjects (sample size was calculated by using WHO sample size calculator)
- Age 30-45 years and
- Hypercholesteremia
Key exclusion criteria (4 listed)
- hypertension,
- diabetes,
- cardiovascular diseases
- systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interval TrainingAll 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. | Other | Study Group |
Primary outcome
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
Functional capacity
Time frame: 3 Months
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 25441400Sydo 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.
- Background: PubMed 16754527Al-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.
- Background: PubMed 27344641Sobol 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.
- Background: PubMed 19453206Faude 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.
- Background: PubMed 20083961Donges 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.
- Background: PubMed 26100312Kiss 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Shabbir, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval Training in people with Obese and Muscle Strength, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurement (Body Mass Index) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693117, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.