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Effect of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Expiratory Flow Volume in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT00998179
First received: October 18, 2009
Last updated: October 19, 2009
Last verified: October 2009
History of Changes
  Purpose

This study aims to investigate the effect of Acu-TENS on forced expiratory volume in one second (FEV1), a test of pulmonary function used to assess airway resistance, during sub-maximal treadmill exercise in healthy subjects.


Condition Intervention
Healthy
 Device: Acu-TENS
Device: Placebo-TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Effect of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Expiratory Flow Volume in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Forced expiratory flow volume in one second (FEV1)and forced vital capacity (FVC) [ Time Frame: before and immediate after the exercise test ] [ Designated as safety issue: Yes ]
  • Forced expiratory flow volume in one second (FEV1) and forced vital capacity (FVC) [ Time Frame: at 15min, 30 min and 45min after the exercise test ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Exercise duration [ Time Frame: Immediately after the exercise test ] [ Designated as safety issue: Yes ]

Enrollment: 11
Arms Assigned Interventions
Active Comparator: Acu-TENS
Application of Acu-TENS prior to exercise
 Device: Acu-TENS
Application of Acu-TENS (with electrical output from the machine)
Placebo Comparator: Placebo-TENS
Application of Acu-TENS (without electrical output from the machine) prior to exercise
 Device: Placebo-TENS
Application of Acu-TENS (without electrical output from the machine)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • With normal health

Exclusion Criteria:

  • Suffered from respiratory, cardiovascular, musculoskeletal, neurological or endocrine disorders
  • No allergic to gel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998179

Locations
China
Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Alice Jones, PhD, FACP Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Prof. Alice Jones, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00998179     History of Changes
Other Study ID Numbers: RS9/10
Study First Received: October 18, 2009
Last Updated: October 19, 2009
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
TENS
acupuncture
FEV1
Normal Healthy subjects

ClinicalTrials.gov processed this record on May 16, 2013