Pulmonary Disease, Chronic ObstructiveSMTNCT02719457
Spot Marching Exercise Test in Chronic Obstructive Pulmonary Disease
A study testing 6 minute walk test (6 MWT) and Spot marching test (SMT) in people with Pulmonary Disease, Chronic Obstructive, run by Khon Kaen University at 2 sites in Thailand.
Trial summary
the aim of this study to assess the relationship and compare physiological response between spot marching exercise test and 6 minute walk test in patient with chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- 6 minute walk test (6 MWT) and Spot marching test (SMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesThailand
- Study dates
- Apr 2016to Dec 2017
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to very severe COPD patients
Who cannot join
- Exacerbate within a month prior, which was a cause of admission to the hospital emergency room or been admitted to hospital.
- Are changed medicines within a month ago.
- Have been used home oxygen therapy.
- Have musculoskeletal or neuromuscular problem affecting balance and walking.
- Using walking aid device.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Khon Kaen Hospital
Khon Kaen, Changwat Khon Kaen, 40000
Vatcharaporn Khaweephab, B.Sc. (PT), +66885615275, vk309@hotmail.com
- Recruiting
Khonkaen univercity
Khonkaen, Khonkaen, 40000
chulee Jones, Ass.PhD, +66845164169, joneschulee@gmail.com
Vatcharaporn Khaweephab
About this study
Official title: the Relationship Between Spot Marching Exercise Test and Six Minute Walk Test in Patient With Chronic Obstructive Pulmonary Disease
the aim of this study to assess the relationship and compare physiological response between spot marching exercise test and 6 minute walk test in patient with chronic obstructive pulmonary disease
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is caused by airway inflammation (increase airway resistance) and destroyed of alveoli (decrease elastic recoil) leading to air trapping (GOLD, 2013). Dyspnea is the most symptom of COPD, a consequence of air trapping. Furthermore, inflammation of COPD has not only been assessed in the airways and lung compartment, but also in the systemic circulation that so called "systemic effects of COPD" such as skeletal muscle atrophy and dysfunction and cardiovascular disease (Wouter, 2002). The occurrence of dyspnea and systemic effects of COPD result in activity and exercise limitation when disease progressive downward.
Exercise testing is the most common determination of exercise limitation and responsiveness of intervention in COPD. It has several exercise protocols including laboratory test and field test. Both test aim to investigate exercise capacity but laboratory test have more parameter detail than field test. In 2013 Borel et al, classified the exercise protocols into three categories by using the workload characteristic (incremental or constant) and the self-paced test. Self-paced test was developed to solve the disadvantage of Incremental and Constant work rate (laboratory test). Moreover,it reflect functional activity and is easy to use. Self-paced test that most famous test such as six minute walk test, step test and stepper test Six minute walk test (6-MWT) assesses distance walked as far as possible within 6 minutes on straight courses. Although the 6-MWT is the most reliable, but it is impractical (Kocks et al., 2011) because of environmental constrain (this test should be performed wild area).
Step test was performed in small area such as hospitals and physician's office. However, these protocols have a risk of falling. Therefore, it was unsuitable for patients who have the imbalance or articular problem.
In 2010, Borel et al., developed six-minute stepper test (6-MST) to solve problem of 6MWT and step test. This study reported that 6-MST used oxygen consumption (VO2) lower than 6MWT. They reasoned that during stepper test, subject move upper limb fewer than walking test. Similarly with Mayo et al., 2001, they found heart rate and expiratory minute ventilation (VE) response of arm performance higher than leg. Therefore, movement of the upper limbs may be increase VO2 peak during exercise test of COPD patient.
Exercise limitation in COPD patient is not only occurs in lower body activity but also occurs during upper task due to systemic effect of disease. Upper body activity was used in daily activity such as lifting, bathing and washing. The almost protocols of exercise test were focused on lower limb test.
The investigators need to find the exercise tests which have the performance in both of upper and lower part movement and are easy to apply in a small setting. In 2013, Premsri et al. studied marching exercise on sympathetic activation in sedentary Thais. And in 2013, Promsrisuk et al. study effects of brisk marching on anthropometry, functional exercise capacity and physical performance among elderly women. Marching exercise have repetitive pattern of arm and leg alternated movement by bending hip between 45-90 degree with knee flexion (Premsri et al.,2013) and also lifting their shoulder flexion up at 90 degree.
Therefore, The investigators interested in the pattern of marching exercise that use both upper and lower extremity and used for exercise test in COPD patient. The investigators expect that marching can increase the performance at maximum level nearby 6-MWT COPD is a major disease in Thailand that not only affects the quality of life for the patient but also is a burden for their family and society at large in terms of the costs of health care and loss of economic activity. Improvements in diagnosis care and treatment can help to minimize the problems but the first stage is diagnosis and assessment. Despite the fact that there are many different exercise protocols that have been used for this purpose there is still an need for a test that is easy to use, especially in the community, and one that involves both arms and legs and is more representative of the activity of daily life. This project is concerned with developing such a test.
Therefore, this study to assess the relationship and compare physiological response between spot marching exercise test and 6 minute walk test in patient with chronic obstructive pulmonary disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- 6 minute walk test (6 MWT), Spot marching test (SMT)
- Keywords
- Exercise testing, COPD, Upper and Lower limb exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minute walk test (6 MWT)Other
6 minute walk test is the standard testing for COPD patients to evaluate their exercise capacity
Spot marching test (SMT)Other
Spot marching test is a new test that developed to evaluate their exercise capacity of COPD patients. This test is alternative method and practical to evaluate exercise capacity. The main benefit of this testing is use a small area to test and movement pattern involve both arm and leg. We expect that SMT may make COPD patient to more dyspnea in a short period of exercise.
| Study group | Role | What they receive |
|---|---|---|
| 6 minute walk test (6 MWT) | Other | patients will be perform the six minute walk test (6 mwt) to evaluate their exercise capacity. Receives: Other: 6 minute walk test (6 MWT) |
| spot marching test (SMT) | Other | patients will be perform the spot marching test (SMT) to evaluate their exercise capacity. Receives: Other: Spot marching test (SMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of step of Spot Marching Test
Measured: up to 6 min
Secondary outcomes (8)
Heart rate
Measured: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
Electrocardiogram (lead II)
Measured: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
Respiratory rate
Measured: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
Blood pressure
include , systolic blood pressure, diastolic blood pressure, mean arterial pressure
Measured: up to 2 minute in recovery phase
peripheral oxygen saturation (SpO2)
Measured: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
partial pressure of end tidal carbondioxide
Measured: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
number of step of 6 minute walk test
Measured: up to 6 min
distance of 6 minute walk test
Measured: up to 6 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vatcharaporn Khaweephab, Khon Kaen University
- Investigators
- Vatcharaporn Khaweephab, Master, Principal investigator, school of physical therapy,faculty of associated medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719457
- Sponsor's protocol ID
- HE581308
- Acronym
- SMT
- Status last verified
- Oct 2016
- First submitted
- 6 Feb 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Relationship Between Spot Marching Exercise Test and Six Minute Walk Test in Patient With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02719457
- Acronym / sponsor ID
- SMT / HE581308
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Exercise testing, COPD, Upper and Lower limb exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Mar 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 aim of this study to assess the relationship and compare physiological response between spot marching exercise test and 6 minute walk test in patient with chronic obstructive pulmonary disease
Detailed description
Chronic obstructive pulmonary disease (COPD) is caused by airway inflammation (increase airway resistance) and destroyed of alveoli (decrease elastic recoil) leading to air trapping (GOLD, 2013). Dyspnea is the most symptom of COPD, a consequence of air trapping. Furthermore, inflammation of COPD has not only been assessed in the airways and lung compartment, but also in the systemic circulation that so called "systemic effects of COPD" such as skeletal muscle atrophy and dysfunction and cardiovascular disease (Wouter, 2002). The occurrence of dyspnea and systemic effects of COPD result in activity and exercise limitation when disease progressive downward.
Exercise testing is the most common determination of exercise limitation and responsiveness of intervention in COPD. It has several exercise protocols including laboratory test and field test. Both test aim to investigate exercise capacity but laboratory test have more parameter detail than field test. In 2013 Borel et al, classified the exercise protocols into three categories by using the workload characteristic (incremental or constant) and the self-paced test. Self-paced test was developed to solve the disadvantage of Incremental and Constant work rate (laboratory test). Moreover,it reflect functional activity and is easy to use. Self-paced test that most famous test such as six minute walk test, step test and stepper test Six minute walk test (6-MWT) assesses distance walked as far as possible within 6 minutes on straight courses. Although the 6-MWT is the most reliable, but it is impractical (Kocks et al., 2011) because of environmental constrain (this test should be performed wild area).
Step test was performed in small area such as hospitals and physician's office. However, these protocols have a risk of falling. Therefore, it was unsuitable for patients who have the imbalance or articular problem.
In 2010, Borel et al., developed six-minute stepper test (6-MST) to solve problem of 6MWT and step test. This study reported that 6-MST used oxygen consumption (VO2) lower than 6MWT. They reasoned that during stepper test, subject move upper limb fewer than walking test. Similarly with Mayo et al., 2001, they found heart rate and expiratory minute ventilation (VE) response of arm performance higher than leg. Therefore, movement of the upper limbs may be increase VO2 peak during exercise test of COPD patient.
Exercise limitation in COPD patient is not only occurs in lower body activity but also occurs during upper task due to systemic effect of disease. Upper body activity was used in daily activity such as lifting, bathing and washing. The almost protocols of exercise test were focused on lower limb test.
The investigators need to find the exercise tests which have the performance in both of upper and lower part movement and are easy to apply in a small setting. In 2013, Premsri et al. studied marching exercise on sympathetic activation in sedentary Thais. And in 2013, Promsrisuk et al. study effects of brisk marching on anthropometry, functional exercise capacity and physical performance among elderly women. Marching exercise have repetitive pattern of arm and leg alternated movement by bending hip between 45-90 degree with knee flexion (Premsri et al.,2013) and also lifting their shoulder flexion up at 90 degree.
Therefore, The investigators interested in the pattern of marching exercise that use both upper and lower extremity and used for exercise test in COPD patient. The investigators expect that marching can increase the performance at maximum level nearby 6-MWT COPD is a major disease in Thailand that not only affects the quality of life for the patient but also is a burden for their family and society at large in terms of the costs of health care and loss of economic activity. Improvements in diagnosis care and treatment can help to minimize the problems but the first stage is diagnosis and assessment. Despite the fact that there are many different exercise protocols that have been used for this purpose there is still an need for a test that is easy to use, especially in the community, and one that involves both arms and legs and is more representative of the activity of daily life. This project is concerned with developing such a test.
Therefore, this study to assess the relationship and compare physiological response between spot marching exercise test and 6 minute walk test in patient with chronic obstructive pulmonary disease
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 minute walk test (6 MWT) | Other | Other: 6 minute walk test (6 MWT)patients will be perform the six minute walk test (6 mwt) to evaluate their exercise capacity. |
| spot marching test (SMT) | Other | Other: Spot marching test (SMT)patients will be perform the spot marching test (SMT) to evaluate their exercise capacity. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild to very severe COPD patients
Key exclusion criteria (5 listed)
- Exacerbate within a month prior, which was a cause of admission to the hospital emergency room or been admitted to hospital.
- Are changed medicines within a month ago.
- Have been used home oxygen therapy.
- Have musculoskeletal or neuromuscular problem affecting balance and walking.
- Using walking aid device.
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 |
|---|---|---|
| 6 minute walk test (6 MWT)6 minute walk test is the standard testing for COPD patients to evaluate their exercise capacity | Other | 6 minute walk test (6 MWT) |
| Spot marching test (SMT)Spot marching test is a new test that developed to evaluate their exercise capacity of COPD patients. This test is alternative method and practical to evaluate exercise capacity. The main benefit of this testing is use a small area to test and movement pattern involve both arm and leg. We expect that SMT may make COPD patient to more dyspnea in a short period of exercise. | Other | spot marching test (SMT) |
Primary outcome
number of step of Spot Marching Test
Time frame: up to 6 min
8 secondary outcomes
Heart rate
Time frame: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
Electrocardiogram (lead II)
Time frame: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
Respiratory rate
Time frame: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
Blood pressure
Time frame: up to 2 minute in recovery phase
peripheral oxygen saturation (SpO2)
Time frame: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
partial pressure of end tidal carbondioxide
Time frame: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min
number of step of 6 minute walk test
Time frame: up to 6 min
distance of 6 minute walk test
Time frame: up to 6 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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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.
Vatcharaporn Khaweephab, Master principal investigator
school of physical therapy,faculty of associated medical sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 minute walk test (6 MWT) and Spot marching test (SMT) in people with Pulmonary Disease, Chronic Obstructive, run by Khon Kaen University at 2 sites in Thailand.
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 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vatcharaporn Khaweephab, Master (+66885615275, vk309@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of step of Spot Marching Test (time frame: up to 6 min). 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 31 Oct 2016.