ObesityNCT05854732
Comparison Of Uninclined And Inclined Treadmill Training In Obese Adults.
A study testing Inclined Treadmill Training and Uninclined Treadmill Training in people with Obesity, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the effects of inclined and uninclined treadmill training on total body fat, lipid profile and quality of life in obese adults. The main question it aims to answer is : Will there be difference between the effectiveness of inclined and uninclined treadmill training on… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Inclined Treadmill Training and Uninclined Treadmill Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Oct 2022to 8 Jun 2023
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants falling in this category would be recruited into the study.
- Males \& females
- Body Mass Index (BMI)> 30 kg / m2 (10).
- Age: 18-25
- Physically independent
- Body fat percentage > 25%
Who cannot join
- Participant failing to fall in this category would be excluded of the study.
- Pregnancy
- Nutrition
- Steroid injections in last 6 months
- Psychomotor dysfunction
- Any infection.
- Any neurological and musculoskeletal problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Uninclined and Inclined Treadmill Training on, Total Body Fat, Lipid Profile and Quality of Life In Obese Adults.
The goal of this clinical trial is to compare the effects of inclined and uninclined treadmill training on total body fat, lipid profile and quality of life in obese adults. The main question it aims to answer is :
Will there be difference between the effectiveness of inclined and uninclined treadmill training on total body fat, lipid profile and quality of life in obese adults.
Participants will be divided into group A and Group B. Group A participants will be considered as a control group with no inclination of the treadmill and speed of 5.0 mph. Whereas Group B participants will be considered as an interventional group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute.
Read the detailed description
Obesity is defined as an excessive or abnormal fat accumulation, with body mass index i.e. BMI ≥ 30kg/m2 presenting multiple conditions related to health. Globally which is associated with high rate of mortality and morbidity and low levels of quality of life in adults. Trainings that include moderate and high intensity exercises are believed to be crucial preventive and anti-obesity treatment strategy now a day. Physical activity is a modifiable factor for obesity. Regular physical activity (PA) is an important component of overall well-being of humans and is well known to improve cardiorespiratory fitness, lipid profile, quality of life which are all negatively correlated with the risks of multiple chronic disease. Treadmill exercises are one of the most commonly known exercise therapy models. It can be modified with inclination like 10 degrees which lies in high intensity activity with HR of 80-90%., uninclined treadmill lies in category of moderate intensity physical activity with HR of 55-60%.Advance studies states that HIIT treadmill with variations in inclination is a good way to decrease body fat mass percentage in obese/overweight individuals. In this study Measurements of the anthropometrics of body like bodyweight, BMI (body mass index), WHR (waist and hip ratio), and body fat mass were calculated pre and post the intervention which shows that there was significant decrease in body fat mass percentage according to study.
Literature was reviewed regarding treadmill training effect on total body fat, and lipid profile in different groups of population. The purpose of this study will be to assess the effect of uninclined and inclined treadmill training on obese adults and its effect on calorie burn. This study will help to determine whether which treadmill training is effective to get more benefits on health in less time and on lipid profile and total body fat in obese adults.
- Conditions
- Obesity
- Being tested
- Inclined Treadmill Training, Uninclined Treadmill Training
- Keywords
- Quality of Life, Cholesterol, Exercise, Physical Activity, Lipid Profile, Obesity, Treadmill
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclined Treadmill TrainingOther
Research subjects will be included in the study according to the inclusion criteria and would be randomized into 2 groups, namely inclined treadmill training group and uninclined treadmill training group and will receive intervention for 6 weeks. The participants will be considered as a experimental group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute. FIIT FORMULA will be considered while providing intervention for 5 days per week to the subjects of each group. The FITT program for the participants will be starting with Warmup of 5 mints with Frequency of 5days/week for 6 weeks with fixed speed of 5.0 mph and increased inclination of 1% after every one minute for 30 minutes ending with Cool down for 5 minutes.
Uninclined Treadmill TrainingOther
Research subjects will be included in the study according to the inclusion criteria and would be randomized into 2 groups, namely inclined treadmill training group and uninclined treadmill training group and will receive intervention for 6 weeks. The participants will be considered as a active comparator with fixed speed of 5.0 mph and fixed inclination. FIIT FORMULA will be considered while providing intervention for 5 days per week to the subjects of each group. The FITT program for the participants will be starting with Warmup of 5 mints with Frequency of 5days/week for 6 weeks with fixed speed of 5.0 mph and fixed inclination for 30 minutes ending with Cool down for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Inclined Treadmill Training Group | Experimental | The Inclined Treadmill Training Group will be considered as an Experimental group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute. The FITT program for the participants will be:
* Warmup: 5 mints
* Frequency: 5days/week for 4 weeks.
* Intensity: fixed speed of 5.0 mph and increased inclination of 1% after every one minute.
* Time: 30 minutes
* Type: 1% Inclined treadmill
* Cool down: 5 mints Receives: Other: Inclined Treadmill Training |
| Uninclined Treadmill Training Group | Active comparator | The uninclined Treadmill Training Group will be considered as active comparator with no inclination of the treadmill and speed of 5.0 mph. The FIIT program for the participants will be:
* Warmup: 5 mints
* Frequency: 5days/week for 4 weeks.
* Intensity fixed speed of 5.0 mph and no inclination.
* Time: 30 minutes
* Type: uninclined treadmill
* Cool down: 5 mints Receives: Other: Uninclined Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Fat
To estimate the overall amount of body fat, the skinfold thickness is measured using a skinfold caliper. This approach is predicated on the idea that subcutaneous fat is measured by the thickness of the skinfold and that body fat is distributed evenly throughout the body. Four skinfolds are measured in order to determine how much body fat is present overall that includes Biceps muscle fold, Thoracic skinfold, Skinfold on the sub scapula and iliac crest skinfold.
Measured: 6 Weeks
Body Mass Index
A scale or balance is a tool used to determine mass or weight.
Measured: 6 Weeks
Lipid Profile Level (cholesterol and triglycerides)
The lipid profile test that is used to check amount of cholesterol and triglycerides in blood.
Measured: 6 weeks
Quality of Life Questionnaire
The WHOQOL, a tool that measures subjective dimensions of quality of life, was created by the World Health Organization (WHO). One of the most well-known tools for comparing quality of life across cultures is the WHOQOL-BREF, which is accessible in more than 40 languages.Each individual question on the WHOQOL-BREF is graded on a response scale, which is defined as a five-point ordinal scale, with scores ranging from 1 to 5. The scores are then linearly translated to a scale from 0 to 100. The mobility, everyday activities, functional ability, energy, pain, and sleep are all part of the physical health domain that are included in the WHOQOL.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start27 Oct 2022
- Primary completion15 Mar 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jawad Naweed, MS-SPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854732
- Sponsor's protocol ID
- REC/01409 FARYAL SHAKOOR
- Status last verified
- Jul 2023
- First submitted
- 3 May 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Uninclined and Inclined Treadmill Training on, Total Body Fat, Lipid Profile and Quality of Life In Obese Adults.
- ClinicalTrials.gov ID
- NCT05854732
- Acronym / sponsor ID
- REC/01409 FARYAL SHAKOOR
- Conditions
- Obesity
- Keywords
- Quality of Life, Cholesterol, Exercise, Physical Activity, Lipid Profile, Obesity, Treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 11 May 2023 (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 goal of this clinical trial is to compare the effects of inclined and uninclined treadmill training on total body fat, lipid profile and quality of life in obese adults. The main question it aims to answer is :
Will there be difference between the effectiveness of inclined and uninclined treadmill training on total body fat, lipid profile and quality of life in obese adults.
Participants will be divided into group A and Group B. Group A participants will be considered as a control group with no inclination of the treadmill and speed of 5.0 mph. Whereas Group B participants will be considered as an interventional group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute.
Detailed description
Obesity is defined as an excessive or abnormal fat accumulation, with body mass index i.e. BMI ≥ 30kg/m2 presenting multiple conditions related to health. Globally which is associated with high rate of mortality and morbidity and low levels of quality of life in adults. Trainings that include moderate and high intensity exercises are believed to be crucial preventive and anti-obesity treatment strategy now a day. Physical activity is a modifiable factor for obesity. Regular physical activity (PA) is an important component of overall well-being of humans and is well known to improve cardiorespiratory fitness, lipid profile, quality of life which are all negatively correlated with the risks of multiple chronic disease. Treadmill exercises are one of the most commonly known exercise therapy models. It can be modified with inclination like 10 degrees which lies in high intensity activity with HR of 80-90%., uninclined treadmill lies in category of moderate intensity physical activity with HR of 55-60%.Advance studies states that HIIT treadmill with variations in inclination is a good way to decrease body fat mass percentage in obese/overweight individuals. In this study Measurements of the anthropometrics of body like bodyweight, BMI (body mass index), WHR (waist and hip ratio), and body fat mass were calculated pre and post the intervention which shows that there was significant decrease in body fat mass percentage according to study.
Literature was reviewed regarding treadmill training effect on total body fat, and lipid profile in different groups of population. The purpose of this study will be to assess the effect of uninclined and inclined treadmill training on obese adults and its effect on calorie burn. This study will help to determine whether which treadmill training is effective to get more benefits on health in less time and on lipid profile and total body fat in obese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inclined Treadmill Training Group | Experimental | Other: Inclined Treadmill TrainingThe Inclined Treadmill Training Group will be considered as an Experimental group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute. The FITT program for the participants will be: * Warmup: 5 mints * Frequency: 5days/week for 4 weeks. * Intensity: fixed speed of 5.0 mph and increased inclination of 1% after every one minute. * Time: 30 minutes * Type: 1% Inclined treadmill * Cool down: 5 mints |
| Uninclined Treadmill Training Group | Active comparator | Other: Uninclined Treadmill TrainingThe uninclined Treadmill Training Group will be considered as active comparator with no inclination of the treadmill and speed of 5.0 mph. The FIIT program for the participants will be: * Warmup: 5 mints * Frequency: 5days/week for 4 weeks. * Intensity fixed speed of 5.0 mph and no inclination. * Time: 30 minutes * Type: uninclined treadmill * Cool down: 5 mints |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants falling in this category would be recruited into the study.
- Males \& females
- Body Mass Index (BMI)> 30 kg / m2 (10).
- Age: 18-25
- Physically independent
Key exclusion criteria (7 listed)
- Participant failing to fall in this category would be excluded of the study.
- Pregnancy
- Nutrition
- Steroid injections in last 6 months
- Psychomotor dysfunction
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 |
|---|---|---|
| Inclined Treadmill TrainingResearch subjects will be included in the study according to the inclusion criteria and would be randomized into 2 groups, namely inclined treadmill training group and uninclined treadmill training group and will receive intervention for 6 weeks. The participants will be considered as a experimental group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute. FIIT FORMULA will be considered while providing intervention for 5 days per week to the subjects of each group. The FITT program for the participants will be starting with Warmup of 5 mints with Frequency of 5days/week for 6 weeks with fixed speed of 5.0 mph and increased inclination of 1% after every one minute for 30 minutes ending with Cool down for 5 minutes. | Other | Inclined Treadmill Training Group |
| Uninclined Treadmill TrainingResearch subjects will be included in the study according to the inclusion criteria and would be randomized into 2 groups, namely inclined treadmill training group and uninclined treadmill training group and will receive intervention for 6 weeks. The participants will be considered as a active comparator with fixed speed of 5.0 mph and fixed inclination. FIIT FORMULA will be considered while providing intervention for 5 days per week to the subjects of each group. The FITT program for the participants will be starting with Warmup of 5 mints with Frequency of 5days/week for 6 weeks with fixed speed of 5.0 mph and fixed inclination for 30 minutes ending with Cool down for 5 minutes. | Other | Uninclined Treadmill Training Group |
Primary outcome
Total Body Fat
Time frame: 6 Weeks
To estimate the overall amount of body fat, the skinfold thickness is measured using a skinfold caliper. This approach is predicated on the idea that subcutaneous fat is measured by the thickness of the skinfold and that body fat is distributed evenly throughout the body. Four skinfolds are measured in order to determine how much body fat is present overall that includes Biceps muscle fold, Thoracic skinfold, Skinfold on the sub scapula and iliac crest skinfold.
Body Mass Index
Time frame: 6 Weeks
A scale or balance is a tool used to determine mass or weight.
Lipid Profile Level (cholesterol and triglycerides)
Time frame: 6 weeks
The lipid profile test that is used to check amount of cholesterol and triglycerides in blood.
Quality of Life Questionnaire
Time frame: 6 Weeks
The WHOQOL, a tool that measures subjective dimensions of quality of life, was created by the World Health Organization (WHO). One of the most well-known tools for comparing quality of life across cultures is the WHOQOL-BREF, which is accessible in more than 40 languages.Each individual question on the WHOQOL-BREF is graded on a response scale, which is defined as a five-point ordinal scale, with scores ranging from 1 to 5. The scores are then linearly translated to a scale from 0 to 100. The mobility, everyday activities, functional ability, energy, pain, and sleep are all part of the physical health domain that are included in the WHOQOL.
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 19 Jul 2023.
- 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.
Jawad Naweed, MS-SPT 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 Inclined Treadmill Training and Uninclined Treadmill Training in people with Obesity, 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 6 inclusion and 7 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 19 Jul 2023. 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?
Total Body Fat (time frame: 6 Weeks). 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?
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 19 Jul 2023.