Sedentary LifestyleNCT04051788
6 Weeks Step Aerobics Training Among Females With Sedentary Life Style.
A study testing Step Aerobics and Aerobic exercise (Lower limb Cycling) in people with Sedentary Lifestyle, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the Effects of 6 weeks of Step Aerobics Training on Pulmonary Functions among females with sedentary life style. Traditional aerobic training programs has great effects to improved pulmonary functions in individuals with sedentary life style but on the other hand there is another type of aerobic training… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Step Aerobics and Aerobic exercise (Lower limb Cycling)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2019to 1 Jul 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female students
- Sedentary life style (low Physical activity)
Who cannot join
- Asthmatic patients
- Any history of Malignancies.
- Students with psychiatric disorders
- Musculoskeletal disease that he was unable to perform aerobic exercises
- Neuromuscular diseases that patient was unable to maintain balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 6 Weeks of Step Aerobics Training on Pulmonary Functions Among Females With Sedentary Life Style.
To determine the Effects of 6 weeks of Step Aerobics Training on Pulmonary Functions among females with sedentary life style. Traditional aerobic training programs has great effects to improved pulmonary functions in individuals with sedentary life style but on the other hand there is another type of aerobic training named step aerobic which is different from traditional training up-to knowledge has less work on pulmonary function but effective on functional score, and walking velocity this gap further need to identify. This study will help us to choose either of training program to get maximum beneficial outcomes particularly on pulmonary function test on female students with sedentary life style.
Read the detailed description
A sedentary lifestyle is defined as an individual living with very little or no physical activity. In daily routine the person spending most of his or her time in watching television, playing games on mobile ,using internet, reading books , often sitting or lying down while doing these activities. It can lead to many health problems and potentially very harmful.
Aerobic exercise is defined as physical exertion that depends upon energy generating process. Aerobic defined as something relating to and involving which required free oxygen. During aerobic exercise maximum use of oxygen can meet the energy demand of the body.
Activities with light to moderate intensities that adequately meet the demands of aerobic metabolism, this can be performed for long period of times.There is a term use aerobic exercise that is "solely" aerobic which is defined as low intensity is required to consumed all carbohydrates in the body and termed them into energy. According to this ,some common examples of aerobic exercise that are walking , swimming , jogging, running and cycling.
Aerobic has great impact on decrease the severity of depression and anxiety . Another study on people who are suffered from depression , asked them to walk for 30 minutes on treadmill and reassess them after 10 days. The results shows significant increase and improvement in their mood and reduction in overall depression episodes and symptoms, they feel fresh and more alive start participate in daily activities . Their negative thoughts which make them depressive also get reduced to some extent .The results shows that physical activity or exercise only for a short period of time may give you a boost in your mood and overall health status. Only a single exercise session has a great impact on the overall mental health.
Another research was conducted on target matching foot stepping to evaluate the proprioception and function of knee osteoarthritis . It includes functional score , walking velocity and overall knee performance to determine the efficacy of knee osteoarthritis. The exercise was designed to perform in sitting position as knee arthritic patients are not able to tolerate in standing position.
- Conditions
- Sedentary Lifestyle
- Being tested
- Step Aerobics, Aerobic exercise (Lower limb Cycling)
- Keywords
- Sedentary Lifestyle, Step Aerobics, Pulmonary Function
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step AerobicsOther
Alternating step knee-lift sequences; alternating leg up, up, down, down patterns; and step kicks, 120 to 126 foot strikes per minute, 20 to 30 minutes per session s, 3 sessions per week up to 6 weeks,The target intensity for all sessions will set at 50-70% heart rate (HR) reserve.
Aerobic exercise (Lower limb Cycling)Other
Lower Limb Aerobic cycling, 20 to 30 minutes per session, 3 sessions per week up to 6 weeks, The target intensity for all sessions will set at 50-70% heart rate (HR) reserve
| Study group | Role | What they receive |
|---|---|---|
| Step Aerobics | Experimental | Step Aerobics Training (120 to 126 foot steps per min) Receives: Other: Step Aerobics |
| Aerobic exercise (Lower limb Cycling) | Active comparator | Lower Limb Aerobic cycling Receives: Other: Aerobic exercise (Lower limb Cycling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Measured: 6th week
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Measured: 6th week
Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Measured: 6th Week
Secondary outcomes (2)
Oxygen Saturation (SpO2)
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Measured: 6th week
Pulse Rate
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Mar 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051788
- Sponsor's protocol ID
- RiphahIU Syeda Rida Fatima
- Status last verified
- Oct 2019
- First submitted
- 8 Aug 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilmore JH. Aerobic exercise and endurance: improving fitness for health benefits. Phys Sportsmed. 2003 May;31(5):45-51. doi: 10.3810/psm.2003.05.367.
PubMed 20086470Hallage T, Krause MP, Haile L, Miculis CP, Nagle EF, Reis RS, Da Silva SG. The effects of 12 weeks of step aerobics training on functional fitness of elderly women. J Strength Cond Res. 2010 Aug;24(8):2261-6. doi: 10.1519/JSC.0b013e3181ddacc6.
PubMed 20634751Jan MH, Tang PF, Lin JJ, Tseng SC, Lin YF, Lin DH. Efficacy of a target-matching foot-stepping exercise on proprioception and function in patients with knee osteoarthritis. J Orthop Sports Phys Ther. 2008 Jan;38(1):19-25. doi: 10.2519/jospt.2008.2512.
PubMed 18357655Khaled M B, A M, S T K, S P C, R D. Effect of traditional aerobic exercises versus sprint interval training on pulmonary function tests in young sedentary males: a randomised controlled trial. J Clin Diagn Res. 2013 Sep;7(9):1890-3. doi: 10.7860/JCDR/2013/5797.3343. Epub 2013 Sep 10.
PubMed 24179890Moradians V, Rahimi A, Javad Moosavi SA, Sahebkar Khorasani FS, Mazaherinejad A, Mortezazade M, Raji H. Effect of Eight-Week Aerobic, Resistive, and Interval Exercise Routines on Respiratory Parameters in Non-Athlete Women. Tanaffos. 2016;15(2):96-100.
PubMed 27904541Cheng YJ, Macera CA, Addy CL, Sy FS, Wieland D, Blair SN. Effects of physical activity on exercise tests and respiratory function. Br J Sports Med. 2003 Dec;37(6):521-8. doi: 10.1136/bjsm.37.6.521.
PubMed 14665592Larson JL, Covey MK, Wirtz SE, Berry JK, Alex CG, Langbein WE, Edwards L. Cycle ergometer and inspiratory muscle training in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):500-7. doi: 10.1164/ajrccm.160.2.9804067.
PubMed 10430720Garrod R, Dallimore K, Cook J, Davies V, Quade K. An evaluation of the acute impact of pursed lips breathing on walking distance in nonspontaneous pursed lips breathing chronic obstructive pulmonary disease patients. Chron Respir Dis. 2005;2(2):67-72. doi: 10.1191/1479972305cd068oa.
PubMed 16279153Spahija J, de Marchie M, Grassino A. Effects of imposed pursed-lips breathing on respiratory mechanics and dyspnea at rest and during exercise in COPD. Chest. 2005 Aug;128(2):640-50. doi: 10.1378/chest.128.2.640.
PubMed 16100149
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 6 Weeks of Step Aerobics Training on Pulmonary Functions Among Females With Sedentary Life Style.
- ClinicalTrials.gov ID
- NCT04051788
- Acronym / sponsor ID
- RiphahIU Syeda Rida Fatima
- Conditions
- Sedentary Lifestyle
- Keywords
- Sedentary Lifestyle, Step Aerobics, Pulmonary Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 9 Aug 2019 (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.
To determine the Effects of 6 weeks of Step Aerobics Training on Pulmonary Functions among females with sedentary life style. Traditional aerobic training programs has great effects to improved pulmonary functions in individuals with sedentary life style but on the other hand there is another type of aerobic training named step aerobic which is different from traditional training up-to knowledge has less work on pulmonary function but effective on functional score, and walking velocity this gap further need to identify. This study will help us to choose either of training program to get maximum beneficial outcomes particularly on pulmonary function test on female students with sedentary life style.
Detailed description
A sedentary lifestyle is defined as an individual living with very little or no physical activity. In daily routine the person spending most of his or her time in watching television, playing games on mobile ,using internet, reading books , often sitting or lying down while doing these activities. It can lead to many health problems and potentially very harmful.
Aerobic exercise is defined as physical exertion that depends upon energy generating process. Aerobic defined as something relating to and involving which required free oxygen. During aerobic exercise maximum use of oxygen can meet the energy demand of the body.
Activities with light to moderate intensities that adequately meet the demands of aerobic metabolism, this can be performed for long period of times.There is a term use aerobic exercise that is "solely" aerobic which is defined as low intensity is required to consumed all carbohydrates in the body and termed them into energy. According to this ,some common examples of aerobic exercise that are walking , swimming , jogging, running and cycling.
Aerobic has great impact on decrease the severity of depression and anxiety . Another study on people who are suffered from depression , asked them to walk for 30 minutes on treadmill and reassess them after 10 days. The results shows significant increase and improvement in their mood and reduction in overall depression episodes and symptoms, they feel fresh and more alive start participate in daily activities . Their negative thoughts which make them depressive also get reduced to some extent .The results shows that physical activity or exercise only for a short period of time may give you a boost in your mood and overall health status. Only a single exercise session has a great impact on the overall mental health.
Another research was conducted on target matching foot stepping to evaluate the proprioception and function of knee osteoarthritis . It includes functional score , walking velocity and overall knee performance to determine the efficacy of knee osteoarthritis. The exercise was designed to perform in sitting position as knee arthritic patients are not able to tolerate in standing position.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step Aerobics | Experimental | Other: Step AerobicsStep Aerobics Training (120 to 126 foot steps per min) |
| Aerobic exercise (Lower limb Cycling) | Active comparator | Other: Aerobic exercise (Lower limb Cycling)Lower Limb Aerobic cycling |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female students
- Sedentary life style (low Physical activity)
Key exclusion criteria (5 listed)
- Asthmatic patients
- Any history of Malignancies.
- Students with psychiatric disorders
- Musculoskeletal disease that he was unable to perform aerobic exercises
- Neuromuscular diseases that patient was unable to maintain balance
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 |
|---|---|---|
| Step AerobicsAlternating step knee-lift sequences; alternating leg up, up, down, down patterns; and step kicks, 120 to 126 foot strikes per minute, 20 to 30 minutes per session s, 3 sessions per week up to 6 weeks,The target intensity for all sessions will set at 50-70% heart rate (HR) reserve. | Other | Step Aerobics |
| Aerobic exercise (Lower limb Cycling)Lower Limb Aerobic cycling, 20 to 30 minutes per session, 3 sessions per week up to 6 weeks, The target intensity for all sessions will set at 50-70% heart rate (HR) reserve | Other | Aerobic exercise (Lower limb Cycling) |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 6th week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Time frame: 6th week
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Peak Expiratory Flow (PEF)
Time frame: 6th Week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
2 secondary outcomes
Oxygen Saturation (SpO2)
Time frame: 6th week
Pulse Rate
Time frame: 6th week
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 24 Oct 2019.
- Background: PubMed 20086470Wilmore JH. Aerobic exercise and endurance: improving fitness for health benefits. Phys Sportsmed. 2003 May;31(5):45-51. doi: 10.3810/psm.2003.05.367.
- Background: PubMed 20634751Hallage T, Krause MP, Haile L, Miculis CP, Nagle EF, Reis RS, Da Silva SG. The effects of 12 weeks of step aerobics training on functional fitness of elderly women. J Strength Cond Res. 2010 Aug;24(8):2261-6. doi: 10.1519/JSC.0b013e3181ddacc6.
- Background: PubMed 18357655Jan MH, Tang PF, Lin JJ, Tseng SC, Lin YF, Lin DH. Efficacy of a target-matching foot-stepping exercise on proprioception and function in patients with knee osteoarthritis. J Orthop Sports Phys Ther. 2008 Jan;38(1):19-25. doi: 10.2519/jospt.2008.2512.
- Background: PubMed 24179890Khaled M B, A M, S T K, S P C, R D. Effect of traditional aerobic exercises versus sprint interval training on pulmonary function tests in young sedentary males: a randomised controlled trial. J Clin Diagn Res. 2013 Sep;7(9):1890-3. doi: 10.7860/JCDR/2013/5797.3343. Epub 2013 Sep 10.
- Background: PubMed 27904541Moradians V, Rahimi A, Javad Moosavi SA, Sahebkar Khorasani FS, Mazaherinejad A, Mortezazade M, Raji H. Effect of Eight-Week Aerobic, Resistive, and Interval Exercise Routines on Respiratory Parameters in Non-Athlete Women. Tanaffos. 2016;15(2):96-100.
- Background: PubMed 14665592Cheng YJ, Macera CA, Addy CL, Sy FS, Wieland D, Blair SN. Effects of physical activity on exercise tests and respiratory function. Br J Sports Med. 2003 Dec;37(6):521-8. doi: 10.1136/bjsm.37.6.521.
- Background: PubMed 10430720Larson JL, Covey MK, Wirtz SE, Berry JK, Alex CG, Langbein WE, Edwards L. Cycle ergometer and inspiratory muscle training in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):500-7. doi: 10.1164/ajrccm.160.2.9804067.
- Background: PubMed 16279153Garrod R, Dallimore K, Cook J, Davies V, Quade K. An evaluation of the acute impact of pursed lips breathing on walking distance in nonspontaneous pursed lips breathing chronic obstructive pulmonary disease patients. Chron Respir Dis. 2005;2(2):67-72. doi: 10.1191/1479972305cd068oa.
- Background: PubMed 16100149Spahija J, de Marchie M, Grassino A. Effects of imposed pursed-lips breathing on respiratory mechanics and dyspnea at rest and during exercise in COPD. Chest. 2005 Aug;128(2):640-50. doi: 10.1378/chest.128.2.640.
- 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.
Iqbal Tariq, MSCPPT 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 Step Aerobics and Aerobic exercise (Lower limb Cycling) in people with Sedentary Lifestyle, 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 2 inclusion and 5 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 24 Oct 2019. 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?
Forced Expiratory Volume in 1 second (FEV1) (time frame: 6th week). The study lists 3 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 NCT04051788, which also lists 9 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 24 Oct 2019.