Back to resultsEffect of Acu-Transcutaneous Electrical Nerve Stimulation (TENS) on Post-Exercise Expiratory Flow Rate in Subjects With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation (TENS)
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma focused on measuring Asthma, Exercise training, TENS, Acupuncture, FEV1
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis with asthma attending regular follow up at respiratory clinic
Exclusion Criteria:
- Allergic to gel
- Suffered from other neurological or cardiovascular or musculoskeletal disorders that may affect their exercise performance
- Suffered from upper respiratory tract infection prior to the study
Sites / Locations
- Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
Applied Acu-TENS prior to exercise
Applied Acu-TENS prior to and during exercise
Applied placebo TENS prior to exercise
Outcomes
Primary Outcome Measures
Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC)
Secondary Outcome Measures
RPE, Exercise duration
Full Information
NCT ID
NCT00824642
First Posted
January 16, 2009
Last Updated
January 16, 2009
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT00824642
Brief Title
Effect of Acu-Transcutaneous Electrical Nerve Stimulation (TENS) on Post-Exercise Expiratory Flow Rate in Subjects With Asthma
Official Title
Effect of Acu-TENS on Post-Exercise Expiratory Flow Rate in Subjects With Asthma- A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate and exercise performance on the subjects with exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Exercise training, TENS, Acupuncture, FEV1
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Applied Acu-TENS prior to exercise
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Applied Acu-TENS prior to and during exercise
Arm Title
Group 3
Arm Type
Placebo Comparator
Arm Description
Applied placebo TENS prior to exercise
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
Applied 45 minutes prior to exercise
Intervention Type
Device
Intervention Name(s)
placebo
Intervention Description
placebo TENS applied prior to exercise
Primary Outcome Measure Information:
Title
Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC)
Time Frame
measured before exercise, immediately after exercise and at 20, 40 and 60 minutes post exercise
Secondary Outcome Measure Information:
Title
RPE, Exercise duration
Time Frame
immediately post exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis with asthma attending regular follow up at respiratory clinic
Exclusion Criteria:
Allergic to gel
Suffered from other neurological or cardiovascular or musculoskeletal disorders that may affect their exercise performance
Suffered from upper respiratory tract infection prior to the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Jones, PhD, FACP
Organizational Affiliation
Department of Rehabilitation Sciences, Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Effect of Acu-Transcutaneous Electrical Nerve Stimulation (TENS) on Post-Exercise Expiratory Flow Rate in Subjects With Asthma
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