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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Vatcharaporn Khaweephab, Master contact

+66885615275

vk309@hotmail.com

Chulee Jones, Doctor contact

+66845164169

joneschulee@gmail.com

Thailand2 sites, 2 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

    Recruiting

Other trials in Thailand

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

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 groups in NCT02719457
Study groupRoleWhat they receive
6 minute walk test (6 MWT)Otherpatients 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)Otherpatients 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.

  1. number of step of Spot Marching Test

    Measured: up to 6 min

Secondary outcomes (8)
  1. Heart rate

    Measured: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min

  2. Electrocardiogram (lead II)

    Measured: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min

  3. Respiratory rate

    Measured: every minute at pre-exercise for 5 min, during exercise test for 6 min and recovery phase for 10 min

  4. Blood pressure

    include , systolic blood pressure, diastolic blood pressure, mean arterial pressure

    Measured: up to 2 minute in recovery phase

  5. 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

  6. 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

  7. number of step of 6 minute walk test

    Measured: up to 6 min

  8. 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.

  1. First posted25 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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)
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

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.

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