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Trial registered on ANZCTR


Registration number
ACTRN12618001683224
Ethics application status
Approved
Date submitted
20/06/2018
Date registered
12/10/2018
Date last updated
12/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A 6-month aquatic exercise programme for individuals with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: benefits for symptoms, health and physical capacity.
Scientific title
A 6-month aquatic exercise programme for individuals with CFS/ME: benefits for symptoms, health and physical capacity
Secondary ID [1] 295096 0
MAS2017F042
Universal Trial Number (UTN)
U1111-1215-2340
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myalgic Encephalomyelitis 308164 0
Chronic Fatigue Syndrome 309405 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307203 307203 0 0
Other physical medicine / rehabilitation
Other 308258 308258 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Self-paced Aquatic exercise

Materials: A climate-controlled pool with a temperature between 27°-30°, and aquatic exercise equipment (e.g. buoyancy belts, pool noodles, kick boards, water dumbbells etc.). Water resistant heart rate monitors and printed RPE scales for participants to rate their level of exertion.

Procedures: The exercise sessions will consist of:
1) A gentle 5-minute warm-up of range of motion exercises and stretches;
2) Approximately 10 – 15 minutes of low-intensity aerobic, strength, balance and flexibility aquatic exercises. The duration may be progressed during the study if symptoms permit.
3) A gentle 5-minute cool-down of stretching.
HR and RPE will be monitored before and after each session, and half-way through each session. Fatigue and tiredness will be recorded using a 0-10 Likert Scale after each session and 24- and 48-hr post-session. Participants will also be asked to keep a symptom and activity diary, with daily entries. Diaries will be collected at the end of each month, with responses collated for qualitative analysis.

Who: the exercise intervention will be delivered by Accredited Clinical Exercise Physiologists (AEPs) with experience in the delivery of aquatic exercise and rehabilitation. They will also be assisted by a second AEP and/or exercise science students.

Mode of delivery: The intervention will be delivered face to face and in a group setting.

Number of times: Exercise sessions will take place 2 per week for the duration of 6 months. The duration of each session will be approximately 30 minutes (may vary depending on each participant's ability). Intensity: participants will pace themselves according to their ability and symptoms and will be rated by each individual's rate of perceived exertion. RPE will remain at <5 (0-10 Borg scale).

Location: the intervention will take place in two regional sites and will occur at a publicly-accessibly pool which will be booked for the duration of the intervention.

The same exercises will be provided to all individuals in the group with alternative suggestions/adaptations made for any individuals that might need it. Instructions on any adaptations will be provided by the clinical exercise physiologist delivering the exercise session.

Adherence to the intervention will be assessed by the researchers (which includes the clinical exercise physiologists conducting the exercise sessions) by monitoring attendance as well as by the use of symptom and activity diaries which will be collected at the end of each month by the researchers. A follow-up text message or call will be made to those participants who missed an exercise session without notifying the researchers.
Intervention code [1] 301432 0
Rehabilitation
Intervention code [2] 301433 0
Treatment: Other
Intervention code [3] 301434 0
Lifestyle
Comparator / control treatment
Active control.

Receiving no treatment and/or usual care. For the purpose of this study, 'usual care' is not based on specific guidelines and is defined as participants going about their daily lives and the management of their condition in the same way as what they would usually have done prior to their inclusion in the study.

The control group will be offered two aquatic sessions plus physical activity advice no later than 3 months after the conclusion of the study.
Control group
Active

Outcomes
Primary outcome [1] 306154 0
Physical capacity:
This component will be assessed by performing a 6 minute walk test,
Timepoint [1] 306154 0
1-2 weeks pre-intervention commencement and again 1-2 weeks post-intervention.
Primary outcome [2] 306155 0
Fatigue:
This component will be assessed by the FACIT fatigue and tiredness scale
Timepoint [2] 306155 0
1-2 weeks pre-intervention commencement and again 1-2 weeks post-intervention.
Primary outcome [3] 306156 0
Pain:
measured by means of a visual analogue pain scale
Timepoint [3] 306156 0
1-2 weeks pre-intervention commencement and again 1-2 weeks post-intervention.
Secondary outcome [1] 347741 0
Primary outcome [4]
Quality of life - as measured by the SF-36 Quality of life questionnaire.
Timepoint [1] 347741 0
Primary timepoint [4]
1-2 weeks pre-intervention commencement and again 1-2 weeks post-intervention.
Secondary outcome [2] 351214 0
Physical capacity: Composite outcome
- as measured by exercise heart rate ( water resistant hear rate monitors) and RPE (measured on a 0-10 RPE visual analogue scale).
Timepoint [2] 351214 0
Peak exercise heart rate will be recorded during each exercise session.
RPE will be monitored and recorded throughout each exercise session.
Secondary outcome [3] 352275 0
Symptoms: Composite outcome
- as measured by the FACIT fatigue and tiredness scale; and a VAS Pain scale, recorded in the participants' symptom and activity diaries
Timepoint [3] 352275 0
Fatigue and pain symptoms will be recorded after each exercise session; after 24; and 48 hours post each exercise session.

Eligibility
Key inclusion criteria
(1) Age range of 18-80 years
(2) GP diagnosis of CFS &/or ME, Post Viral Syndrome, Post Viral Fatigue Syndrome or Chronic Mononucleosis by means of the Canadian Consensus criteria or the Fukuda criteria
(3) Does not currently participate in regular vigorous exercise or physical activity
(4) Is able to communicate in English
(5) Able to give informed, signed consent
(6) Able to commit the time required for participating in this research
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Cardiovascular condition that makes physical activity hazardous
(2) Severe chronic obstructive pulmonary disease or uncontrolled asthma
(3) A diagnosed medical condition other than CFS/ME which causes chronic or severe fatigue
(4) Metabolic, renal, endocrine, autoimmune, neurological or inflammatory disease that makes physical activity hazardous
(5) A current musculoskeletal injury that prevents physical activity
(6) Mental illness that makes participation in this research hazardous
(7) Infectious diseases
(8) Non-swimmer
(9) Allergic to chlorine or other pool chemicals
(10) Pregnant

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation: each group in each arm of the study will consist of at least 15 participants to provide a power of 0.80 (calculated from 6MWT data from our prior pilot study).
Data will be analysed using IBM SPSS Statistics and NVivo software.
Descriptive statistics will be provided for data variables.
Assumptions of normality will be tested using the Shapiro-Wilk test.
Independent t-tests and chi-square analyses will be used to explore differences in demographics between the two groups at baseline.
Repeated measures ANOVA with factors including groups and time.
The magnitude of the change between pre- and post-intervention values will be reported using a modified Cohen’s effect size (ES) with the following descriptors applied to ES thresholds: 0.0 - 0.2 trivial, 0.2 – 0.6 small, 0.6 – 1.2 moderate, 1.2 – 2.0 large, > 2.0 very large.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/01/2019
Actual
Date of last participant enrolment
Anticipated
28/02/2019
Actual
Date of last data collection
Anticipated
13/09/2019
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 11077 0
Lismore Base Hospital - Lismore
Recruitment postcode(s) [1] 22884 0
2480 - Lismore
Recruitment postcode(s) [2] 22885 0
2480 - Caniaba
Recruitment postcode(s) [3] 22886 0
2480 - Dunoon
Recruitment postcode(s) [4] 22887 0
2480 - Goonellabah
Recruitment postcode(s) [5] 22888 0
2480 - Wyrallah
Recruitment postcode(s) [6] 23039 0
2480 - Chilcotts Grass
Recruitment postcode(s) [7] 23040 0
2480 - Eltham
Recruitment postcode(s) [8] 23041 0
4550 - Landsborough
Recruitment postcode(s) [9] 23042 0
4550 - Mount Mellum
Recruitment postcode(s) [10] 23043 0
4551 - Caloundra
Recruitment postcode(s) [11] 23044 0
4552 - Bald Knob
Recruitment postcode(s) [12] 23045 0
4553 - Mooloolah
Recruitment postcode(s) [13] 23046 0
4556 - Buderim
Recruitment postcode(s) [14] 23047 0
4557 - Mooloolaba
Recruitment postcode(s) [15] 23048 0
4560 - Sunshine Coast
Recruitment postcode(s) [16] 23049 0
4572 - Alexandra Headland
Recruitment postcode(s) [17] 23050 0
4567 - Noosa Heads
Recruitment postcode(s) [18] 23051 0
2479 - Bangalow
Recruitment postcode(s) [19] 23052 0
2478 - Ballina
Recruitment postcode(s) [20] 23053 0
2477 - Alstonville
Recruitment postcode(s) [21] 23054 0
2473 - Evans Head
Recruitment postcode(s) [22] 23055 0
4556 - Sippy Downs

Funding & Sponsors
Funding source category [1] 299678 0
Charities/Societies/Foundations
Name [1] 299678 0
Mason Foundation
Country [1] 299678 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Military Road, East Lismore, NSW 2480
or
PO Box 157, Lismore, NSW, 2480
Country
Australia
Secondary sponsor category [1] 299015 0
None
Name [1] 299015 0
Address [1] 299015 0
Country [1] 299015 0
Other collaborator category [1] 280184 0
University
Name [1] 280184 0
University of the Sunshine Coast
Address [1] 280184 0
90 Sippy Downs Dr,
Sippy Downs QLD 4556
Country [1] 280184 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300578 0
Southern Cross University Human Research and Ethics Committee
Ethics committee address [1] 300578 0
Military Road, East Lismore, NSW, 2480
or
PO Box 157, Lismore, NSW, 2480
Ethics committee country [1] 300578 0
Australia
Date submitted for ethics approval [1] 300578 0
23/07/2018
Approval date [1] 300578 0
29/08/2018
Ethics approval number [1] 300578 0
ECN-18-131

Summary
Brief summary
The study will investigate the effectiveness of six months of self-paced aquatic exercise for individuals with CFS/ME, compared to usual care (control group). Outcome measures will include physical capacity (resting heart rate, resting blood pressure, oxygen saturation, perceived exertion (RPE), 6 minute walk test, hand grip strength, sit to stand test, sit and reach test, and the Apley's shoulder test); health and symptoms (full blood test with white cell differential, assessment of orthostatic blood pressure, FACIT fatigue and tiredness scale, and a VAS Pain scale); and quality of life (SF-36 Quality of Life; Hospital Anxiety and Depression Scale [HADS], surveys, and open-ended questions in interviews).

Participants will be allocated to an exercise or control group, and supervised, self-paced exercise sessions will be held twice a week in a heated pool. The results will be applicable to all age groups who suffer CFS/ME, with or without FM.
This is a proof-of-concept study with a view to conducting a larger, longitudinal trial to provide further evidence for clinical practice.
It is hypothesized that (1) the aquatic exercise group will improve their exercise tolerance, physiological responses and quality of life, and reduce symptoms of fatigue, pain and anxiety compared to the control group; (2) the number of immune cells (leukocytes) will increase in the exercise group compared to the control group.
Trial website
Trial related presentations / publications
Public notes
Aquatic exercise has not been trialed long-term for CFS/ME but our short-term pilot data showed promising results, especially symptom reduction and improved fitness after only five weeks.

Contacts
Principal investigator
Name 84110 0
Dr Sonja Coetzee
Address 84110 0
Southern Cross University
School of Health and Human Sciences
Military Rd, East Lismore 2480
Office P1.48
or
PO Box 157, Lismore, NSW, 2480
Country 84110 0
Australia
Phone 84110 0
+61 2 6626 9290
Fax 84110 0
Email 84110 0
[email protected]
Contact person for public queries
Name 84111 0
Sonja Coetzee
Address 84111 0
Southern Cross University
School of Health and Human Sciences
Military Rd, East Lismore 2480
Office P1.48
or
PO Box 157, Lismore, NSW, 2480
Country 84111 0
Australia
Phone 84111 0
+61 2 6626 9290
Fax 84111 0
Email 84111 0
[email protected]
Contact person for scientific queries
Name 84112 0
Sonja Coetzee
Address 84112 0
Southern Cross University
School of Health and Human Sciences
Military Rd, East Lismore 2480
Office P1.48
or
PO Box 157, Lismore, NSW, 2480
Country 84112 0
Australia
Phone 84112 0
+61 2 6626 9290
Fax 84112 0
Email 84112 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23638Study protocol  [email protected]
23639Informed consent form  [email protected]
23640Ethical approval  [email protected]

Results publications and other study-related documents

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