NCT02719457

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

February 6, 2016

Last Update Submit

October 27, 2016

Conditions

Keywords

Exercise testingCOPDUpper and Lower limb exercise

Outcome Measures

Primary Outcomes (1)

  • number of step of Spot Marching Test

    up to 6 min

Secondary Outcomes (8)

  • Heart rate

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

  • Electrocardiogram (lead II)

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

  • Respiratory rate

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

  • Blood pressure

    up to 2 minute in recovery phase

  • peripheral oxygen saturation (SpO2)

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

  • +3 more secondary outcomes

Study Arms (2)

6 minute walk test (6 MWT)

OTHER

patients will be perform the six minute walk test (6 mwt) to evaluate their exercise capacity.

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.

Other: Spot marching test (SMT)

Interventions

6 minute walk test is the standard testing for COPD patients to evaluate their exercise capacity

6 minute walk test (6 MWT)

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.

spot marching test (SMT)

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild to very severe COPD patients

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Khon Kaen Hospital

Khon Kaen, Changwat Khon Kaen, 40000, Thailand

RECRUITING

Khonkaen univercity

Khonkaen, Khonkaen, 40000, Thailand

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vatcharaporn Khaweephab, Master

    school of physical therapy,faculty of associated medical sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vatcharaporn Khaweephab, Master

CONTACT

Chulee Jones, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Khon Kaen Hospital

Study Record Dates

First Submitted

February 6, 2016

First Posted

March 25, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations