Sedentary LifestylePhase 1NCT02645292
Comparison Between Stair Climbing and One Mile Walking in Relation to Cardiorespiratory Fitness
A Phase 1 study testing 1 mile walk using treadmill and Stair Climbing in people with Sedentary Lifestyle, run by Universiti Tunku Abdul Rahman.
Trial summary
The worldwide epidemic of physical inactivity is rising significantly and the main cause is sedentary lifestyle. In this era of globalization and rapid advancement of technology, people are chasing after worldly matters, leading them to abandon the most important factor in their life and that's their body. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- 1 mile walk using treadmill and Stair Climbing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2015
- Phase
- Phase 1
- 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
- Sedentary Adults
- Height:160cm to 170cm
- Willing to participate
Who cannot join
- -
About this study
The worldwide epidemic of physical inactivity is rising significantly and the main cause is sedentary lifestyle. In this era of globalization and rapid advancement of technology, people are chasing after worldly matters, leading them to abandon the most important factor in their life and that's their body. Most people are leading a sedentary lifestyle as they indulge themselves in their never-ending work. There is a significant lack of awareness on the importance of physical activity and cardiorespiratory fitness to health as people are focusing more on factors such as smoking, cholesterol and hypertension. The purpose of this study is to evaluate the effectiveness of stair climbing (SC) and 1 mile walking (1MW) in relation to cardiorespiratory responses and fitness.
Read the detailed description
The incidences of chronic diseases and cardiovascular diseases are escalating rapidly and fingers are being pointed to physical inactivity and poor cardiorespiratory fitness as one of the few main 'predictors of premature mortality. According to WHO (2015), 23% of adults above the age of 18 years old were insufficiently physically active in 2010, with men scoring 20% and women 27%. Comparing high income and low income countries, 26% of men and 35% of women of high income countries was said to be insufficiently physically active compared to 12% of men and 24% of women of low income countries. This may be due to the fact that people of high income countries are more engrossed in chasing after worldly matters at work and preferring a sedentary lifestyle at home after work. Globally, adolescents between the age of 11 to 17 years old scored a high percentage of 81% of being insufficiently physically active and this may be because adolescents prefer to spend more time on internet, playing games on computers or watching dramas or movies. In the Physical Activity Statistics 2015 by the British Heart Foundation, it is reported that North West of England has the highest level of physical inactivity with 26% for men and 31% for female. It was also mentioned that household incomes play a role in the level of physical activity in England. In 2012, 29% men and 34% women from the lowest quintile of household income in England were physically inactive compared to 11% men and 18% women of the highest quintile of household income.[1] In Malaysia a research conducted on physical activity index among Malaysian youth and out of 1801 respondents, 23% men and 31.3% women were insufficiently physically active.[2] In another research on the Prevalence and Factors Associated with Physical Inactivity among Malaysian Adults, the overall prevalence of physical inactivity was 43.7%.[3] Similar to other researchers, results also show that women are more physically inactive at 9 465 (50.5%) out of 18 744 female respondents compared to men at 5367 (35.3%) out of 15205 male respondents. It is important to ensure that everyone participates in physical activities in effort to improve their health and indirectly reduce the risk of mortality. Hence, the researcher aims to compare the effects of stair climbing and one mile walking in relation to cardiorespiratory responses and fitness to find which one is better compared to other as these type of activates can be performed in any settings and does not require sophisticated equipments.
- Conditions
- Sedentary Lifestyle
- Being tested
- 1 mile walk using treadmill, Stair Climbing
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mile walk using treadmillDevice
Walk for 1 mile on treadmill (American Motion Fitness, 8800D) at self selected speed as fast as participant can without any inclination.
Stair ClimbingDevice
Climb 14 flights of stairs at self selected speed. No double step at a time and running allowed.
| Study group | Role | What they receive |
|---|---|---|
| 1 mile Walk using treadmill | Experimental | Walking for 1 mile on treadmill (American Motion Fitness, 8800D) as fast as participant can, without any inclination Receives: Device: 1 mile walk using treadmill |
| Stair Climbing | Experimental | 30 meters of vertical distance to be covered (14 flights of stairs with a total of 154 steps) Receives: Device: Stair Climbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Fitness Index
''Change'' is being assessed
Measured: At baseline and at end of 4 weeks of intervention
V02max
''Change'' is being assessed
Measured: At baseline and at end of 4 weeks of intervention
Secondary outcomes (4)
Recovery Heart Rate
''Change'' is being assessed
Measured: At baseline and at end of 4 weeks of intervention
Systolic & Diastolic Blood Pressure
''Change'' is being assessed
Measured: At baseline and at end of 4 weeks of intervention
Respiratory Rate
''Change'' is being assessed
Measured: At baseline and at end of 4 weeks of intervention
Rate of Perceived Exertion
''Change'' is being assessed
Measured: At baseline and at end of 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645292
- Sponsor's protocol ID
- U/SERC/83/2015
- Status last verified
- Dec 2015
- First submitted
- 28 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: It is confidential
Publications
1. Townsend N, Wickramasinghe K, Williams J, Bhatnagar P, Rayner M (2015). Physical Activity Statistics 2015. British Heart Foundation:London
2. Salamudin, N., & Harun, M. (2013). Physical Activity Index among Malaysian Youth. Asian Social Science, 9(12).
Ying C, Kuay LK, Huey TC, Hock LK, Hamid HA, Omar MA, Ahmad NA, Cheong KC. Prevalence and factors associated with physical inactivity among Malaysian adults. Southeast Asian J Trop Med Public Health. 2014 Mar;45(2):467-80.
PubMed 24968689
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Stair Climbing and One Mile Walking in Relation to Cardiorespiratory Fitness
- ClinicalTrials.gov ID
- NCT02645292
- Acronym / sponsor ID
- U/SERC/83/2015
- Conditions
- Sedentary Lifestyle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Jan 2016 (estimated)
- 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 worldwide epidemic of physical inactivity is rising significantly and the main cause is sedentary lifestyle. In this era of globalization and rapid advancement of technology, people are chasing after worldly matters, leading them to abandon the most important factor in their life and that's their body. Most people are leading a sedentary lifestyle as they indulge themselves in their never-ending work. There is a significant lack of awareness on the importance of physical activity and cardiorespiratory fitness to health as people are focusing more on factors such as smoking, cholesterol and hypertension. The purpose of this study is to evaluate the effectiveness of stair climbing (SC) and 1 mile walking (1MW) in relation to cardiorespiratory responses and fitness.
Detailed description
The incidences of chronic diseases and cardiovascular diseases are escalating rapidly and fingers are being pointed to physical inactivity and poor cardiorespiratory fitness as one of the few main 'predictors of premature mortality. According to WHO (2015), 23% of adults above the age of 18 years old were insufficiently physically active in 2010, with men scoring 20% and women 27%. Comparing high income and low income countries, 26% of men and 35% of women of high income countries was said to be insufficiently physically active compared to 12% of men and 24% of women of low income countries. This may be due to the fact that people of high income countries are more engrossed in chasing after worldly matters at work and preferring a sedentary lifestyle at home after work. Globally, adolescents between the age of 11 to 17 years old scored a high percentage of 81% of being insufficiently physically active and this may be because adolescents prefer to spend more time on internet, playing games on computers or watching dramas or movies. In the Physical Activity Statistics 2015 by the British Heart Foundation, it is reported that North West of England has the highest level of physical inactivity with 26% for men and 31% for female. It was also mentioned that household incomes play a role in the level of physical activity in England. In 2012, 29% men and 34% women from the lowest quintile of household income in England were physically inactive compared to 11% men and 18% women of the highest quintile of household income.[1] In Malaysia a research conducted on physical activity index among Malaysian youth and out of 1801 respondents, 23% men and 31.3% women were insufficiently physically active.[2] In another research on the Prevalence and Factors Associated with Physical Inactivity among Malaysian Adults, the overall prevalence of physical inactivity was 43.7%.[3] Similar to other researchers, results also show that women are more physically inactive at 9 465 (50.5%) out of 18 744 female respondents compared to men at 5367 (35.3%) out of 15205 male respondents. It is important to ensure that everyone participates in physical activities in effort to improve their health and indirectly reduce the risk of mortality. Hence, the researcher aims to compare the effects of stair climbing and one mile walking in relation to cardiorespiratory responses and fitness to find which one is better compared to other as these type of activates can be performed in any settings and does not require sophisticated equipments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 mile Walk using treadmill | Experimental | Device: 1 mile walk using treadmillWalking for 1 mile on treadmill (American Motion Fitness, 8800D) as fast as participant can, without any inclination |
| Stair Climbing | Experimental | Device: Stair Climbing30 meters of vertical distance to be covered (14 flights of stairs with a total of 154 steps) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary Adults
- Height:160cm to 170cm
- Willing to participate
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| 1 mile walk using treadmillWalk for 1 mile on treadmill (American Motion Fitness, 8800D) at self selected speed as fast as participant can without any inclination. | Device | 1 mile Walk using treadmill |
| Stair ClimbingClimb 14 flights of stairs at self selected speed. No double step at a time and running allowed. | Device | Stair Climbing |
Primary outcome
Physical Fitness Index
Time frame: At baseline and at end of 4 weeks of intervention
''Change'' is being assessed
V02max
Time frame: At baseline and at end of 4 weeks of intervention
''Change'' is being assessed
4 secondary outcomes
Recovery Heart Rate
Time frame: At baseline and at end of 4 weeks of intervention
Systolic & Diastolic Blood Pressure
Time frame: At baseline and at end of 4 weeks of intervention
Respiratory Rate
Time frame: At baseline and at end of 4 weeks of intervention
Rate of Perceived Exertion
Time frame: At baseline and at end of 4 weeks of intervention
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 1 Jan 2016.
- Background1. Townsend N, Wickramasinghe K, Williams J, Bhatnagar P, Rayner M (2015). Physical Activity Statistics 2015. British Heart Foundation:London
- Background2. Salamudin, N., & Harun, M. (2013). Physical Activity Index among Malaysian Youth. Asian Social Science, 9(12).
- Background: PubMed 24968689Ying C, Kuay LK, Huey TC, Hock LK, Hamid HA, Omar MA, Ahmad NA, Cheong KC. Prevalence and factors associated with physical inactivity among Malaysian adults. Southeast Asian J Trop Med Public Health. 2014 Mar;45(2):467-80.
- Individual participant dataSharing planned: No. It is confidential
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1 mile walk using treadmill and Stair Climbing in people with Sedentary Lifestyle, run by Universiti Tunku Abdul Rahman.
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 3 inclusion and 1 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 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical Fitness Index (time frame: At baseline and at end of 4 weeks of intervention). The study lists 2 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 NCT02645292, which also lists 3 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 1 Jan 2016.