Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001015831
Ethics application status
Approved
Date submitted
14/09/2012
Date registered
20/09/2012
Date last updated
24/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of acupuncture and instruction on post-exercise recovery in healthy adults
Scientific title
The effects of acupuncture and instruction on cardiovascular recovery from maximal exercise in healthy adults: An investigation using the balanced placebo design
Secondary ID [1] 281080 0
Nil
Universal Trial Number (UTN)
U1111-1133-7700
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular recovery from exercise 287292 0
Condition category
Condition code
Cardiovascular 287553 287553 0 0
Normal development and function of the cardiovascular system
Alternative and Complementary Medicine 287784 287784 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a single 2hr session before which they will be required to abstain from alcohol and moderate-to-intense exercise for 24hrs and cigarettes and caffeine for 4hrs.

Upon screening participants will have their height and weight taken for further analysis including calculating Body mass index (BMI). Participants will be instructed to lie in a supine position on a plinth for 15 min, prior to the performing of the exercise protocol, to evaluate resting metabolic parameters, and to establish a standardised baseline condition.

Following 15 min of supine rest, participants will perform a graded exercise test to volitional fatigue on an electronically braked cycle ergometer (Velotron, Racermate, Boulder, CO, USA) using a ramped protocol to be consistent with previous similar research. The cycle ergometer is initially set to 0 Watts (W), with increments thereafter set at 15 W/min. The participant will also be required to maintain their pedal rate at 60 revolutions per min (RPM). The exercise test will be terminated if : (1) The participant can no longer maintain a minimum cadence of 60 revolutions per min (RPM) or if the subject requests to terminate the testing. Upon completion of exercise, the participant will be told which treatment they have been allocated to receive (real acupuncture, placebo acupuncture or control).

An experienced acupuncturist trained in Traditional Chinese Medicine delivered the traditional acupuncture treatment. The primary acupuncture points included PC6, ST36, LU7, and REN17. PC6 is located on the anterior aspect of the forearm, between the tendons of the palmaris longus and the flexor carpi radialis, 2 cun proximal to the palmar wrist crease. ST36 is on the anterior aspect of the leg, on the line connecting. LU7 is on the radial aspect of the forearm, between the tendons of the abductor pollicis longus and the extensor pollicis brevis muscle, in the groove for the abductor pollicis longus tendon, 1.5B-cun superior to the palmar wrist crease. REN17 is located on the anterior thoracic region, at the same level as the fourth intercostal space, on the anterior median line. PC6 and ST6 both appear to have consistent regulatory effects on cardiovascular function. LU7 is a classic point for promoting lung function. REN17 is indicated for regulating Qi in the chest and treating breathlessness. PC6, ST36, and LU7 have been used in previous research showing effects of acupuncture on exercise recovery and exercise capacity. Single-use disposable stainless steel needles (0.25 x 40mm for body acupuncture) were used. Acupuncture needles were inserted to tissue level and stimulated manually (3x180 rotations of approximately 3Hz) when the participant assumed the supine recovery position. The needles were stimulated after 10 min of needle retention and upon removal at 20 min of total needle retention, the participant will then rest for a further 40 mins (resting for a total of 60mins).

While the participant may be told they are recieveing real acupuncture expectancy is being controlled by being randomised into;
1.Acupuncture with high expectancy (AH). Participants randomised to this group received traditional acupuncture treatment and were informed that they were receiving traditional acupuncture treatment.
2.Acupuncture with low expectancy (AL). Participants randomised to this group received traditional acupuncture treatment but were informed that they were receiving placebo acupuncture.
Intervention code [1] 285588 0
Treatment: Other
Comparator / control treatment
Placebo acupuncture was delivered using the Park device. The placebo needle itself is able to slide into the handle, which increases the appearance that the skin is being penetrated, although there is no actual penetration. The placebo needle is placed 1-2cm away from acupuncture points used in the acupuncture method. The protocol in terms of frequency and intensity of needle stimulation and resting time is identical to that of the real acupuncture protocol.

While the participant may be told they are recieveing placebo acupuncture expectancy is being controlled by being randomised into
3.Placebo acupuncture with high expectancy (PH). Participants randomised to this group received placebo acupuncture and were informed that they were receiving placebo acupuncture.
4.Placebo acupuncture with low expectancy (PL). Participants randomised to this group received placebo acupuncture but were informed that they were receiving traditional acupuncture treatment.
5.Control (i.e. no treatment) (C). Participants allocated to this condition received no treatment and were informed that they were receiving no treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 287879 0
Heart rate will be measures via telemetry (Polar XL, Stamford, CT).
Timepoint [1] 287879 0
- Every 5 Mins pre-exercise for 15 minutes
- Every 3 minutes during exercise until volitional fatigue
- At fatigue
- Every 5 minutes post-exercise for 60 minutes
Primary outcome [2] 287880 0
Blood pressure will measured via auscultation and recorded as two components; systolic blood pressure and diastolic blood pressure.
Timepoint [2] 287880 0
- Every 5 Mins pre-exercise for 15 minutes
- Every 3 minutes during exercise until volitional fatigue
- At fatigue
- Every 5 minutes post-exercise for 60 minutes
Secondary outcome [1] 298976 0
Oxygen consumption data, including, respiratory exchange ratio (RER), volume of oxygen consumed per minute (VO2), volume of carbon dioxide (VCO2) expired per minute, and respiratory exchange ratio (RER), will be monitored continuously using a Masterscreen CPX metabolic cart (Jaeger, Wurzburg, Germany) using breath-by-breath analysis protocol with the sampling frequency set at 15 seconds. Before each test O2 and CO2 sensors were calibrated using high-grade calibration gas with certified gas concentrations (O2 = 16%, CO2 = 5% and N2 = balance). Ventilation volume was measured using a Triple V digital flow meter and calibrated using a 3L calibration syringe (Hans Rudolph, Kansas, MO, USA).
Timepoint [1] 298976 0
Measured continuously throughout the session including; pre-exercise resting period, during exercise and post-exercise resting period at 15 second intervals
Secondary outcome [2] 299154 0
Blood lactate
Timepoint [2] 299154 0
- 10 minutes into 15 minutes of the pre-exercise resting period
- 5 minutes post exercise
- 10 minute intervals thereafter for 60 minutes
Secondary outcome [3] 299155 0
Rating of perceived exertion (RPE) according to Borg's scale
Timepoint [3] 299155 0
- Every 3 minutes during exercise

Eligibility
Key inclusion criteria
- Aged between 18-30 years old
- Engage in exercise a minimum of 3 times per week (30 minute sessions) at a moderate to high intensity
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Previous use of acupuncture as those who have had acupuncture could not be adequately blinded
- A phobia of needles
- Taking medication other than the contraceptive pill as this may affect the response to the acupuncture
- Any acute or chronic medical condition(s) that would make participation in the experimental conditions potentially hazardous or outcomes measures impossible to assess.

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)
1. Participants were recruited by means of convenience sampling via advertisements posted on notice boards throughout UWS Campbelltown Campus and on the UWS website.
2. The principal investigator met with potentially eligible participants prior to performance of the experimental protocol. Individuals were pre-screened for eligibility using a standardised checklist. If eligible, the individual was presented with a detailed Participant Information Sheet, which detailed the study procedure and potential risks. The principal investigator responded to all queries related to participation prior to the solicitation of written informed consent. The participant was then pre-screened for exercise participation using a standardised pre-exercise screening questionnaire. General demographic data were also collected at this time.
3. The treatment allocated to each participant is concealed in a sealed envelop which are numbered from 1 to 75.
4. The participant is then allocated to their corresponding numbered envelop (e.g. the first participant will recieve envelop number 1) at the commencement of the rest/treatment period. The participant is told which treatment (real, placebo or no treatment) they will be recieving.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation was done via a computer randomisation program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
This study employed a 2 x 2 between-subjects balanced placebo design with an additional no-treatment control group
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285917 0
University
Name [1] 285917 0
University of Western Sydney
Country [1] 285917 0
Australia
Primary sponsor type
Individual
Name
Dr. Birinder SinghD Cheema
Address
School of Biomeducal and Health Sciences
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 284740 0
Individual
Name [1] 284740 0
Dr. Ben Colagiuri
Address [1] 284740 0
School of Psychology (A18)
University of Sydney
Sydney NSW 2006
Country [1] 284740 0
Australia
Secondary sponsor category [2] 284749 0
Individual
Name [2] 284749 0
Dr. Caroline A. Smith
Address [2] 284749 0
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country [2] 284749 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287946 0
UWS Human Research Ethics Committee
Ethics committee address [1] 287946 0
Ethics committee country [1] 287946 0
Australia
Date submitted for ethics approval [1] 287946 0
28/04/2010
Approval date [1] 287946 0
06/08/2010
Ethics approval number [1] 287946 0
H8366

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34609 0
Address 34609 0
Country 34609 0
Phone 34609 0
Fax 34609 0
Email 34609 0
Contact person for public queries
Name 17856 0
Dr. Bobby Cheema
Address 17856 0
School of Science and Health
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 2751
Country 17856 0
Australia
Phone 17856 0
+61 2 4620 3795
Fax 17856 0
+61 2 4620 3792
Email 17856 0
[email protected]
Contact person for scientific queries
Name 8784 0
Dr. Bobby Cheema
Address 8784 0
School of Science and Health
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 2751
Country 8784 0
Australia
Phone 8784 0
+61 2 4620 3795
Fax 8784 0
+61 2 4620 3792
Email 8784 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of acupuncture and instruction on physiological recovery from maximal exercise: A balanced-placebo controlled trial.2016https://dx.doi.org/10.1186/s12906-016-1213-y
N.B. These documents automatically identified may not have been verified by the study sponsor.