NCT00998179

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

October 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
Last Updated

October 20, 2009

Status Verified

October 1, 2009

First QC Date

October 18, 2009

Last Update Submit

October 19, 2009

Conditions

Healthy

Keywords

TENSacupunctureFEV1Normal Healthy subjects

Outcome Measures

Primary Outcomes (2)

  • Forced expiratory flow volume in one second (FEV1)and forced vital capacity (FVC)

    before and immediate after the exercise test

  • Forced expiratory flow volume in one second (FEV1) and forced vital capacity (FVC)

    at 15min, 30 min and 45min after the exercise test

Secondary Outcomes (1)

  • Exercise duration

    Immediately after the exercise test

Study Arms (2)

Acu-TENS

ACTIVE COMPARATOR

Application of Acu-TENS prior to exercise

Device: Acu-TENS

Placebo-TENS

PLACEBO COMPARATOR

Application of Acu-TENS (without electrical output from the machine) prior to exercise

Device: Placebo-TENS

Interventions

Acu-TENSDEVICE

Application of Acu-TENS (with electrical output from the machine)

Acu-TENS
Placebo-TENSDEVICE

Application of Acu-TENS (without electrical output from the machine)

Placebo-TENS

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With normal health

You may not qualify if:

  • Suffered from respiratory, cardiovascular, musculoskeletal, neurological or endocrine disorders
  • No allergic to gel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University

Hong Kong, China

Location

Study Officials

  • Alice Jones, PhD, FACP

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 20, 2009

Last Updated

October 20, 2009

Record last verified: 2009-10

Locations

CN(1)