None listed
Conditions
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.
Interventions
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
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.
Sponsors
A/Prof Jennifer Alison
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 86 Years
Healthy volunteers
No
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).
Exclusion criteria
Musculoskeletal, neurological or cardiovascular conditions as the main limiting factors for exercise. Cognitive impairment.
Outcome results
None listed