NCT00824642

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started May 2005

Typical duration for not_applicable asthma

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

Study Start

First participant enrolled

May 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
Last Updated

January 19, 2009

Status Verified

January 1, 2009

Enrollment Period

3 years

First QC Date

January 16, 2009

Last Update Submit

January 16, 2009

Conditions

Keywords

AsthmaExercise trainingTENSAcupunctureFEV1

Outcome Measures

Primary Outcomes (1)

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

    measured before exercise, immediately after exercise and at 20, 40 and 60 minutes post exercise

Secondary Outcomes (1)

  • RPE, Exercise duration

    immediately post exercise

Study Arms (3)

Group 1

EXPERIMENTAL

Applied Acu-TENS prior to exercise

Device: Transcutaneous electrical nerve stimulation (TENS)

Group 2

EXPERIMENTAL

Applied Acu-TENS prior to and during exercise

Device: Transcutaneous electrical nerve stimulation (TENS)

Group 3

PLACEBO COMPARATOR

Applied placebo TENS prior to exercise

Device: placebo

Interventions

Applied 45 minutes prior to exercise

Group 1Group 2
placeboDEVICE

placebo TENS applied prior to exercise

Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis with asthma attending regular follow up at respiratory clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Asthma

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Alice Jones, PhD, FACP

    Department of Rehabilitation Sciences, 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
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

May 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 19, 2009

Record last verified: 2009-01

Locations