Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001192774p
Ethics application status
Not yet submitted
Date submitted
8/08/2022
Date registered
6/09/2022
Date last updated
6/09/2022
Date data sharing statement initially provided
6/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
To understand how heart rate variability and physical activity can be used effectively in the management of fatigue
Scientific title
To assess the effects of using heart rate variability and physical activity as an intervention in the management of fatigue in those who suffer fatigue as a primary or secondary symptom.
Secondary ID [1] 307724 0
None
Universal Trial Number (UTN)
U1111-1281-3824
Trial acronym
BOUNCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic fatigue 327290 0
Myalgic Encephalomyelitis 327291 0
Long Covid 327292 0
post cancer fatigue 327293 0
fibromyalgia 327294 0
Condition category
Condition code
Other 324421 324421 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
Pre intervention measures: Online version of the De Paul Symptom Questionnaire. This will take approximately 20-30 minutes. Participants will be asked to complete four questionnaires (RAND-36 Health Survey, DASS – Depression, anxiety, and stress scale, MFIS – Modified fatigue impact scale, PSFS – patient specific functional scale to enable, this should take approximately 30 minutes.
Participants will be given an activity watch and a HR monitor to wear around their chest. They will be asked to wear the activity watch and to collect HRC measures using the polar strap for a period of three days prior to the intervention starting. Participants will meet with a clinical exercise physiologist (CEP) either online or face to face depending on your location. In this meeting the clinical exercise physiologist will explain to participants how to record, interpret, and log the details into the diary. The CEP will also take participants through some physical activity that corresponds to your HRV. They will discuss how to use each participants' HRV data to select the appropriate exercise. The CEP will also help prescribe exercise sessions and also personalised exercise intensity for the rest of the week and this will be up to 150 minutes, depending on the participants ability and exercise history. In week two you will meet with the CEP; they will teach participants when and how to increase daily functional activity. The CEP will help participants manage physical activity over the next 10 weeks, by meeting with them once per week for between 45-60 minutes and helping to set appropriate goals for physical activity for the week, alongside this the CEP will be reviewing and adjusting the program on a weekly basis. Each week participants should expect to complete up to 2 and a half hours of physical activity, this is 30 minutes daily. Participants will have the option of completing one of the sessions supervised. This may occur at a local community centre, at home or in a commercial fitness centre.
The level of exercise completed low, moderate or vigorous will be assessed with the heart rate monitor. Adherence to the exercise will be monitored with a physical activity diary which will be checked during the weekly visits to the CEP. Exercise that may be prescribed during the intervention vary from stretching, resistance exercise, walking, jogging, but this will be individualised and dependent on what the participant is capable of. Following the 12 weeks, you will complete the same questionnaires that they completed at the start: RAND-36 Health Survey, DASS – Depression, anxiety, and stress scale, MFIS – Modified fatigue impact scale, PSFS – patient specific functional scale to enable, this should take approximately 30 minutes. Follow up questionnaires will be sent at 3 months and six months post intervention.
Intervention code [1] 324199 0
Lifestyle
Comparator / control treatment
It is anticipated that some people may not want to take part in the physical activity component of the trial. These individuals will be asked to be control individuals for the trial, but will be matched for fatigue, age, and gender to individuals in the intervention. Control individuals will be completing the same questionnaires and follow ups, but will not have any CEP meetings of physical activity prescribed.
Control group
Active

Outcomes
Primary outcome [1] 332233 0
RAND-36 will be completed by participants - Quality of Life will be assessed with this tool.
Timepoint [1] 332233 0
Baseline, 3 months and six months post intervention commencement.
The primary timepoint is 3 months form commencement of the study.
Primary outcome [2] 332234 0
Depression, anxiety and stress scale (DASS). Mental health is being assessed by this tool.
Timepoint [2] 332234 0
Baseline, 3 months and six months post intervention commencement.
The primary timepoint is 3 months form commencement of the study.
Primary outcome [3] 332235 0
Modified fatigue impact scale
Timepoint [3] 332235 0
Baseline, 3 months and six months post intervention commencement.
The primary timepoint is 3 months form commencement of the study.
Secondary outcome [1] 412666 0
Patient specific functional scale
Timepoint [1] 412666 0
Baseline, 3 months and six months post intervention commencement.

Eligibility
Key inclusion criteria
Individuals who meet the Fukuda and International Consensus Criteria for chronic fatigue or have been diagnosed with chronic fatigue by their GP or treating specialist. Individuals with secondary fatigue, such as long covid, post cancer fatigue, and fibromyalgia will also be accepted into the research study, if they have been diagnosed by a GP or specialist.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who have not been diagnosed with a fatigue condition and who do not meet the Fukuda, and International Consensus Criteria. Participants will be asked to only complete exercise as directed by the Clinical Exercise Physiologist across the 12 weeks of the study. The participants should continue to take any medications already prescribed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will self select to be part of the exercise group or not. Those who choose not to take part in the exercise will be asked if they would like to be control participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is anticipated that 80 participants will be included in the sample size. The sample size has been based on previous research where the prediction of structured exercise estimated that 50% of those who start the intervention may drop out.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
2/10/2023
Actual
Date of last data collection
Anticipated
2/04/2024
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 24936 0
New Zealand
State/province [1] 24936 0
North and South Island

Funding & Sponsors
Funding source category [1] 311997 0
Commercial sector/Industry
Name [1] 311997 0
Specialised Health - Exercise Physiology
Country [1] 311997 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Specialised Health - Exercise Physiology
Address
3/426 Manchester Street,
St Albans
Christchurch
8014
Country
New Zealand
Secondary sponsor category [1] 313491 0
None
Name [1] 313491 0
Address [1] 313491 0
Country [1] 313491 0
New Zealand
Other collaborator category [1] 282393 0
University
Name [1] 282393 0
Massey University
Address [1] 282393 0
School of Sport, Exercise and Nutrition,
Massey University
PTC 2.03, PN621,
Palmerston North
4414
Country [1] 282393 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311419 0
HDEC
Ethics committee address [1] 311419 0
Health and Disability Ethics Committee,
Ministry of Health,
PO Box 5013,
Wellington
6140
Ethics committee country [1] 311419 0
New Zealand
Date submitted for ethics approval [1] 311419 0
26/09/2022
Approval date [1] 311419 0
Ethics approval number [1] 311419 0

Summary
Brief summary
The purpose of the study is to use heart rate variability to guide the type of physical activity prescribed and completed to reduce fatigue in participants whom fatigue is a primary or secondary symptom. It is anticipated that by using heart rate variability to guide exercise, participants will feel less fatigued and will be able to return to the workplace. It is expected that this study will provide knowledge on the benefits of using heart rate variability as a tool to help manage physical activity and fatigue related conditions, which will benefit communities who are currently also trying to understand how to help people with such conditions.
It is anticipated that 80 participants will take part in the research study within New Zealand. Participants may choose to complete the exercise intervention straight away, six months later, or not at all. At the start of the research study, you will be asked to complete some questionnaires about your health, wellbeing and work hours. These questionnaires will be repeated at 3 and 6 months. All participants will receive an activity watch and a heart rate strap to wear throughout the study. You will be expected to wear the heart rate strap and watch daily and record your heart rate variability score each day upon waking each day. You will also be asked to keep a diary detailing your heart rate variability scores and physical activity completed. A Clinical Exercise Physiologist (CEP), will help you learn how to measure your heart rate variability as well as how to keep a diary of your recordings. The exercise intervention will be 12 weeks in length. During the exercise intervention, you will be offered 12 hours of contact with a CEP, this will usually be once a week. The Clinical Exercise Physiologist will prescribe you exercises based on your heart rate variability score. This will be up to 150 minutes of exercise at a level appropriate with your heart rate variability score over the week along with having one 45–60-minute session with a clinical exercise physiologist.
Trial website
None
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 121030 0
Miss Carymn Barnes
Address 121030 0
Specialised Health - Exercise Physiology
3/426 Manchester Street
St Albans
Christchurch
8014
Country 121030 0
New Zealand
Phone 121030 0
+64 21 224 7527
Fax 121030 0
Email 121030 0
carmyn@specialisedhealth.nz
Contact person for public queries
Name 121031 0
Dr Lynette Hodges
Address 121031 0
School of Sport, Exercise and Nutrition
Massey University,
Private Bag 11-222
Palmerston North
4442
Country 121031 0
New Zealand
Phone 121031 0
+64 63569099
Fax 121031 0
Email 121031 0
l.d.hodges@massey.ac.nz
Contact person for scientific queries
Name 121032 0
Dr Lynette Hodges
Address 121032 0
School of Sport, Exercise and Nutrition
Massey University,
Private Bag 11-222
Palmerston North
4442
Country 121032 0
New Zealand
Phone 121032 0
+64 63569099
Fax 121032 0
Email 121032 0
l.d.hodges@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participants data will not be made available to the public.


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
No additional documents have been identified.