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Trial registered on ANZCTR


Trial ID
ACTRN12612000693820
Ethics application status
Approved
Date submitted
27/06/2012
Date registered
28/06/2012
Date last updated
28/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of application of Transcutaneous Electrical Nerve Stimulation (TENS) on acupunture points (Acu-TENS) compared to Sham-TENS on breathlessness and exercise capacity in people with chronic obstructive pulmonary disease (COPD)
Scientific title
Effect of application of Transcutaneous Electrical Nerve Stimulation (TENS) on acupunture points (Acu-TENS) compared to Sham-TENS on breathlessness and exercise capacity in people with chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 280429 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 286397 0
Condition category
Condition code
Respiratory 286651 286651 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised crossover study.

Participants will attend for 4 visits, each visit will last for 2 hours. Visit 1 and 2 will be conducted within a week and the subsequent visits will be conducted weekly.

At the initial visit, characteristics of each participant will be measured, including lung function tests and exercise capacity. Exercise capacity will be measured using the Incremental shuttle walk test performed twice, and the endurance shuttle walk test performed once. All tests will be assessed and supervised by a physiotherapist. The tests will be terminated if participants fail to follow the preset speed or feel too dyspnoeic to continue. On the second visit, participants will perform two endurance shuttle walk tests to ensure familiarisation. Participants will be randomised to receive either the intervention (Acu-TENS) or placebo control (Sham-TENS) on visits 3 and 4. On visit 3 and 4, participant will perform one endurance shuttle walk test with no intevention followed by 45 minutes of either Acu-TENS or Sham-TENS which will be continued during the second endurance shuttle walk test.

Intervention:
Transcutaneous Electrical Nerve Stimulation (TENS) applied on acupuncture points, i.e. Acu-TENS. Acu-TENS will be applied to the acupoints for reducing breathlessness, i.e. EX-B1, Dingchuan located on the lower borer of 7th Cervical vertebrae.
Intervention code [1] 284789 0
Treatment: Devices
Comparator / control treatment
Sham TENS refers to the application of Transcutaneous Electrical Nerve Stimulation (TENS) on non-acupuncture points, i.e. patella (with electrical stimulation).
Control group
Placebo

Outcomes
Primary outcome [1] 287054 0
Endurance shuttle walk test time using the endurance shuttle walk test.
Timepoint [1] 287054 0
Endurance shuttle walk test time from test 1 (no intervention) and test 2 (with intervention/ placebo) on the same test day.
Secondary outcome [1] 297275 0
Dyspnoea using modified Borg category-ratio scale (0-10).
Timepoint [1] 297275 0
Dyspnoea score will be compared at isotime (time of the shortest endurance shuttle walk test of the two tests performed on each test day).
Secondary outcome [2] 297276 0
Endurance shuttle walk test distance using the endurance shuttle walk test.
Timepoint [2] 297276 0
Endurance shuttle walk test distance from test 1 (no intervention) and test 2 (with intervention/ placebo) on the same test day.

Eligibility
Key inclusion criteria
Patients diagnosed with COPD with the FEV1/ FVC less than 0.7 and disease severity from mild to severe according to the GOLD criteria (i.e. Mild FEV1 > 80% predicted to very severe FEV1 < 30% predicted).
Minimum age
40 Years
Maximum age
86 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal, neurological or cardiovascular conditions as the main limiting factors for exercise.
Cognitive impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with COPD who are registered as volunteers for research will be contacted.

The intervention sequence will be run by a randomization software and the order of intervention will be concealed in an opaque envelope by an investigator not involved in data collection.

The intervention or placebo will be applied by an independent clinician who is not involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The intervention sequence will be generated by a randomization software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285534 0
University
Name [1] 285534 0
The University of Sydney
Address [1] 285534 0
Discipline of Physiotherapy, University of Sydney
75 East Street, Lidcombe, NSW 2141, Australia
Country [1] 285534 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jennifer Alison
Address
Discipline of Physiotherapy, University of Sydney
75 East Street, Lidcombe, NSW 2141, Australia
Country
Australia
Secondary sponsor category [1] 284378 0
None
Name [1] 284378 0
Address [1] 284378 0
Country [1] 284378 0
Other collaborator category [1] 260779 0
Individual
Name [1] 260779 0
Dr. Shirley Ngai
Address [1] 260779 0
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [1] 260779 0
Hong Kong
Other collaborator category [2] 260782 0
Individual
Name [2] 260782 0
Prof. Alice Jones
Address [2] 260782 0
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [2] 260782 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287194 0
Ethics Review Committee (RPAH Zone), Sydney Local Health District NSW
Ethics committee address [1] 287194 0
Research Development Office, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW 2050
Ethics committee country [1] 287194 0
Australia
Date submitted for ethics approval [1] 287194 0
21/09/2011
Approval date [1] 287194 0
25/10/2011
Ethics approval number [1] 287194 0
11/RPAH/427

Summary
Brief summary
Participants with COPD usually complain of dyspnoea during exercise which limits their exercise tolerance. Previous studies have shown that one session of Acu-TENS could alleviate breathlessness in participants with COPD (Lau and Jones, 2008; Ngai et al., 2011). The aim of the study is to evaluate the effect of Acu-TENS compared with Sham-TENS on exercise capacity and breathlessness in people with COPD.
People with COPD who meet the inclusion and exclusion criteria will be recruited. After informed consent, each participant will attend for 4 visits. During the first visit, participants will be asked to perform two incremental shuttle walk test (ISWT) for determining the intensity level for the endurance shuttle walk test (ESWT). On the second visit, participants will be asked to perform two ESWTs to ensure accurate measure of endurance exercise capacity. On the third and fourth visit, participants will be randomly assigned to receive either Acu-TENS or Sham-TENS. Randomization sequence will be generated by a randomisation software by an investigator who is not involved in the data collection, and will be concealed in an opaque envelope. Both assessor and the patient will be blinded to the intervention. On visit 3 and 4, participants will perform one ESWT, followed by 45-minute of either Acu-TENS/ Sham-TENS which will be continued during the second ESWT.
The change in endurance shuttle walk test time on visit 3 and 4 will be the primary outcome measure. Secondary outcome measures will be level of dyspnoea at isotime and distance walked in endurance shuttle walk test.
The findings of the study will elucidate whether Acu-TENS will improve endurance exercise capacity and reduce breathlessness, thus, enabling people with COPD to improve functional capacity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34129 0
Address 34129 0
Country 34129 0
Phone 34129 0
Fax 34129 0
Email 34129 0
Contact person for public queries
Name 17376 0
A/ Prof Jennifer Alison
Address 17376 0
Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney,
75 East Street, Lidcombe, NSW 2141
Country 17376 0
Australia
Phone 17376 0
+61 2 93519371
Fax 17376 0
+61 2 93519601
Email 17376 0
jennifer.alison@sydney.edu.au
Contact person for scientific queries
Name 8304 0
A/ Prof Jennifer Alison
Address 8304 0
Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney,
75 East Street, Lidcombe, NSW 2141
Country 8304 0
Australia
Phone 8304 0
+61 2 93519371
Fax 8304 0
+61 2 93519601
Email 8304 0
jennifer.alison@sydney.edu.au