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Trial registered on ANZCTR


Registration number
ACTRN12612001241820
Ethics application status
Approved
Date submitted
20/11/2012
Date registered
23/11/2012
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Date results provided
31/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on the effects of intermittent and graded exercise compared to no exercise for optimising health and reducing symptoms in Chronic Fatigue Syndrome (CFS)patients.
Scientific title
A pilot study on the effects of intermittent and graded exercise compared to no exercise for optimising health and reducing symptoms in Chronic Fatigue Syndrome (CFS)patients.
Secondary ID [1] 281565 0
Nil
Universal Trial Number (UTN)
U1111-1137-0634
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Fatigue Syndrome 287847 0
Condition category
Condition code
Other 288217 288217 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Inflammatory and Immune System 288196 288196 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled trial of intermittent exercise training compared to graded exercise and standard care. Graded exercise is the current recommended exercise approach to CFS and consists of self-paced (e.g. low intensity) steady state exercise at a constant workload for a short period of time; as the patient gradually improves their fitness, the length of time and eventually the intensity is increased in a gradual graded manner provided no adverse symptoms occur. Intermittent or interval exercise consists of short blocks of exercise, at low-moderaste intensity with a rest interval in between bouts of exercise e.g. 1 min low intensity cycling, followed by 1 minute of rest, followed by 1 minute of cycling; the total time spent exercising can be gradually increased whilst maintaining the rest or unloaded exercise intervals. The participants will be randomly allocated to one of 3 groups. Each group will consist of 20 participants to provide a power of 80% for the study (based on data from Gordon et al., 2010), using an aprior test to compute required sample size, given alpha (p = 0.05), power and effect size for an F test, and looking at ANOVA fixed effects, main effects and interactions (GPower). Volunteers will participate in 3 aerobic exercise sessions (cycling on a cycle ergometer) per week, consisting of:
(1) a warm up of 5 minutes of unloaded cycling for both ITE and GE groups;
(2) either a steady state (constant effort) low-moderate intensity cycling period, (50% VO2peak, RPE 3 Modified Borg Scale) initially for 10 minutes (GE group) OR an intermittent exercise block of 1 minute of moderate intensity cycling (60% VO2peak, RPE 4-5) alternated with 1 minute of unloaded or very low intensity/unloaded cycling (20-30% VO2peak, RPE 1-2), totalling 20 minutes;
(3) cool down of 5 minutes unloaded cycling plus stretching of main muscle groups for both groups.
Over the 12 weeks of the project, we aim to progress the duration of SS exercise towards 20 min, as tolerated by the participant, and to progress the ITE participants towards intervals of 2-3 min of moderate intensity cycling, alternated with 1 minute intervals of low intensity cycling, totalling 25-30 min duration. All group sessions will be supervised by one of the research team (who are accredited exercise physiologists) with assistance from post-graduate Masters of Clinical Exercise Physiology students, who are studying to become accredited exercise physiologists.
The total intervention duration will be 12 weeks for graded, intermittent and control groups.
Intervention code [1] 286087 0
Treatment: Other
Comparator / control treatment
Usual care (lifestyle advice). The advice will be provided initially by the participant's GP and also by the research team at the initial screening consultation (i.e. face to face advice with a summary information sheet for the participant). Lifestyle advice and support can be regularly maintained by the researchers over the 12 week period of the study by direct coversation, phone and email messages/support at the request of the participant.
Control group
Active

Outcomes
Primary outcome [1] 288397 0
Improved physiological adaptations to exercise (reduced RPE, heart rate and blood pressure). Rate of perceived exertion (RPE) is assessed using a standard 10 point Borg Scale where the participant is asked how hard they feel they are exercising; heart rate will be measured using a 12 lead ECG during pre- and post-study exercise tests, and during exercise sessions by using a Polar heart rate monitor; blood pressurs will be monitored constantly during pre- and post-study exercise testing and also during exercise sessions using a standard sphygomanometer and adult-sized cuff and stethoscope.
Timepoint [1] 288397 0
Baseline (Week 0) to post-study (Week 13)
Primary outcome [2] 288395 0
Increased VO2peak, measured pre- and post-study by open circuit spirometry (Sensormedics) metabolic cart) and breath-by-breath analysis. The test protocol is a cycle test starting with a 3 minute warm up of unloaded cycling, followed by 1 minute increments of 10 watts (W) until a VO2 plateau is achieved (i.e. VO2 does not increase although workload continues to increase and/or RER > 1.15 and/or peak heart rate within 10 beats per minute of age-predicted maximum and/or volitional exhaustion). The test may also be stopped at the request of the participant if they feel too fatigued. If a sub-maximal value is achieved at this stage, a peak VO2 value can be extrapolated using a linear regression.
Timepoint [2] 288395 0
Baseline (week 0) to post-study (Week 13).
Primary outcome [3] 288396 0
Increased lymphocyte function and reduced inflammatoy cytokines measured pre- and post-study by comparison of immune cell counts, lymphocyte (CD4, CD8, CD19, NK) function, and inflammatory cytokines (IFN-y, IL-1) in both exercise groups and control group. cell counts will be measured by by full blood count (standard pathology); lymphocyte subsets by cell count using a Facscanto flow cytometer (Becton Dickinson); lymphocyte function will be analysed using proliferative assays with flow cytometric fluorescent analysis; inflammatory cytokines will be assessed using standard ELISA assays.
Timepoint [3] 288396 0
Baseline (week 0) to post-study (Week 13).
Secondary outcome [1] 300051 0
Reduced fatigue and symptoms (Cummins Fatigue Scale)
Timepoint [1] 300051 0
Baseline (Week 0) to post-study (Week 13)

Eligibility
Key inclusion criteria
Medical diagnosis of Chronic Fatigue Syndrome: persistent and disabling, and/or recurring, fatigue lasting for more than 6 months, that does not result from physical exertion and that is not alleviated by rest. Other symptoms include muscle weakness and pain, ongoing medical symptoms such as swollen lymph nodes and fever, poor sleep, poor concentration and reduced quality of life.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed cardiac and/or respiratory disease; joint or muscle condition/disease other than CFS, that is contraindicated for exercise; any mental health condition that may affect exercise participation or safety of participant and researchers.

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)
possible participants will be recruited through newspaper advertisements, fliers available at GP surgeries, the university campus and community notice boards. Possible participants may contact the researchers (phone or email) and the project will be explained to them in detail. Provided the participants have no contraindications to exercise and have provided informed consent, they will be screened for cardiovascular risk factors and will undergo baseline testing consisting of: medical history; anthropometry; resting blood sample to provide a full cell count (Sullivan Nicolaides Pathology analysis)plus blood and serum for lymphocyte (CD3+CD4+, CD3+CD8+, CD3+CD16+CD56+, CD4+CD45+, CD19) and cytokine (IL-1, IFN-y) flowcytometric and ELISA assays; VO2max cycling exercise test; spirometry;quality of life/wellness, fatigue and depression questionnaires (Personal Well Being Index, Cummins, 2006; the Revised Clinical Interview Schedule - measures the presence of Fatigue; The Fatigue Scale - nature of fatigue, mental and physical and the Fatigue Severity Scale, both of which are specific for CFS). These outcome measures will be assessed pre- and post-training. ALLOCATION: de-indentified participants will be randomly assigned to an exercise group (graded or interval training) or the control group, using a random number generator. The allocation concealment was carried out by central randomisation from a computer at another campus.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software, producing a sequence generation. The allocation concealment was carried out by central randomisation from a computer at another campus.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Pre- and post-training comparisons students t -test; group and time comparisons of immunological and physiological data by repeated measures ANOVA with Bon Feroni adjustment.. Frequencies of symptoms and abnormal findings examined using Pearsons Chi square

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2013
Actual
20/05/2013
Date of last participant enrolment
Anticipated
Actual
27/01/2014
Date of last data collection
Anticipated
Actual
28/01/2014
Sample size
Target
60
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286352 0
Charities/Societies/Foundations
Name [1] 286352 0
Southern Cross University School of Health and Human Sciences
Country [1] 286352 0
Australia
Primary sponsor type
Individual
Name
Suzanne Broadbent
Address
P 1.14
School of Health and Human Sciences
Southern Cross University
PO Box 157
Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 285141 0
Individual
Name [1] 285141 0
Rosanne Coutts
Address [1] 285141 0
P 1.10
School of Health and Human Sciences
Southern Cross University
PO Box 157
Lismore NSW 2480
Country [1] 285141 0
Australia
Other collaborator category [1] 277187 0
Individual
Name [1] 277187 0
Professor John Dwyer
Address [1] 277187 0
Faculty of Medicine
University of NSW Scool of Medical Sciences
High St
Randwick
NSW 2031
Country [1] 277187 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288434 0
Southern Cross University HREC
Ethics committee address [1] 288434 0
Ethics committee country [1] 288434 0
Australia
Date submitted for ethics approval [1] 288434 0
15/12/2012
Approval date [1] 288434 0
26/03/2013
Ethics approval number [1] 288434 0
ECN-14-159

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

Contacts
Principal investigator
Name 34958 0
Dr Suzanne Broadbent
Address 34958 0
Office P1.14, P Block
Southern Cross University,
PO Box 157 Lismore
NSW 2480
Country 34958 0
Australia
Phone 34958 0
+61 2 66203394
Fax 34958 0
+61 2 66269135
Email 34958 0
suzanne.broadbent@scu.edu.au
Contact person for public queries
Name 18205 0
Dr Suzanne Broadbent
Address 18205 0
P 1.14
School of Health and Human Sciences
Southern Cross University
PO Box 157
Lismore NSW 2480
Country 18205 0
Australia
Phone 18205 0
+61 2 66203394
Fax 18205 0
+61 2 66269583
Email 18205 0
suzanne.broadbent@scu.edu.au
Contact person for scientific queries
Name 9133 0
Dr Suzanne Broadbent
Address 9133 0
P 1.14
School of Health and Human Sciences
Southern Cross University
PO Box 157
Lismore NSW 2480
Country 9133 0
Australia
Phone 9133 0
+61 2 66203394
Fax 9133 0
+61 2 66269583
Email 9133 0
suzanne.broadbent@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial completed 10 years ago and results published


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
EmbaseExercise therapy for chronic fatigue syndrome.2015https://dx.doi.org/10.1002/14651858.CD003200.pub3
EmbaseIntermittent and graded exercise effects on NK cell degranulation markers LAMP-1/LAMP-2 and CD8+CD38+ in chronic fatigue syndrome/myalgic encephalomyelitis.2017https://dx.doi.org/10.14814/phy2.13091
N.B. These documents automatically identified may not have been verified by the study sponsor.