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Trial registered on ANZCTR


Registration number
ACTRN12621000379819p
Ethics application status
Submitted, not yet approved
Date submitted
5/02/2021
Date registered
6/04/2021
Date last updated
6/04/2021
Date data sharing statement initially provided
6/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A mixed methods feasibility study of a COMorbidity-adapted Exercise program for older adults with low BACK pain (COME-BACK)
Scientific title
A mixed methods feasibility study of a COMorbidity-adapted Exercise program for older adults (>65 years) with low BACK pain (COME-BACK)
Secondary ID [1] 303367 0
None
Universal Trial Number (UTN)
Trial acronym
COME-BACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 320630 0
Condition category
Condition code
Musculoskeletal 318485 318485 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 318486 318486 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be three phases for the single group, comorbidity-adapted exercise program (intervention): diagnostic, development and intervention phases.

Diagnostic phase: At Macquarie University, a primary health care practitioner (PHCP) will obtain a thorough medical history, and then perform a physical and functional examination to determine contraindications and restrictions to an exercise program. This is expected to take 45 minutes.

Development phase: In the first exercise program session, anticipated to be 60 minutes duration and will be held at Macquarie University, the PHCP will design and tailor the session to adapt the exercise program to the older individual, and provide patient education. The exercise program will be consist of lower extremity and back extensor muscle-strength training, aerobic training, core stability exercises, balance training and lower limb and back stretching based on an inventory. Adapting the exercise program for individual patients will include tailoring the exercise frequency, intensity, timing, and exercise type based on the presenting comorbid condition(s). At this session the PHCPs will provide patient education, explore the participant’s goals, motivations and barriers to an exercise program and provide the participant with paper-based GLA:D Back pain education material.

Intervention phase: The exercise program will consist of 16 sessions throughout the eight-week exercise program. There will be two PCHP supervised sessions per week with each session being approximately 60 minutes in duration. Exercise program sessions will be provided in a group exercise session, at Macquarie University. The Borg Rate of Perceived Exertion scale will be used to monitor training intensity during each supervised exercise program session, and it is expected that exercise programs sessions will be of low to moderate intensity. Educational and coaching strategies will supplement the comorbidity-adapted exercise program throughout each supervised session, with adaptation to the exercise program patient directed. Attendance will be recorded at each exercise session throughout the study and adherence to the exercise program will be assessed using an exercise diary to document the proportion of available sessions attended, the completion of each session, whether participants could complete each component of the exercise program (i.e duration and/or repetitions) and whether participants could complete the full duration of the exercise program. After their last session, participants will be interviewed by the research assistant to explore the feasibility of the exercise program and barriers and facilitators to their participation.
Intervention code [1] 319675 0
Treatment: Other
Intervention code [2] 319914 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326446 0
Patient recruitment
Timepoint [1] 326446 0
Six months post commencement of recruitment. We will determine how long it takes to recruit 24 participants, and report how many older adults are screened for and meet eligibility criteria.
Primary outcome [2] 326754 0
Retention
Timepoint [2] 326754 0
Six months post-commencement of the intervention. Study retention rates will report the percentage of participants who complete the eight-week exercise program and provide complete data through follow up.
Primary outcome [3] 326755 0
Intervention adherence
Timepoint [3] 326755 0
Eight weeks post-commencement of the intervention. Attendance will be recorded at each exercise session throughout the study and adherence to the exercise program will be assessed using an exercise diary to document the proportion of available sessions attended, the completion of each session, whether participants could complete each component of the exercise program (i.e duration and/or repetitions) and whether participants could complete the full duration of the exercise program.
Secondary outcome [1] 391514 0
Barriers and Facilitators for Clinicians. PCHPs will report difficulties in collecting clinical outcomes and difficulties in prescribing the exercise program using a diary. One on one semi-structured interviews will also be held for PCHPs at the end of the exercise program to discuss the barriers and facilitators of delivering the exercise program.
Timepoint [1] 391514 0
12 weeks post-commencement of the intervention.
Secondary outcome [2] 391515 0
The 6-minute walk test will be carried out by patients on a 30 m walkway to assess aerobic capacity and endurance.
Timepoint [2] 391515 0
Four weeks (mid-treatment) and eight weeks (post-treatment).
Secondary outcome [3] 391516 0
Low back pain severity will be assessed using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Timepoint [3] 391516 0
SMS daily for eight weeks
Secondary outcome [4] 391517 0
Oswestry Disability Index
Timepoint [4] 391517 0
Four weeks (mid-treatment) and eight weeks (post-treatment).
Secondary outcome [5] 391518 0
Health-related quality of life will be measured using the EQ-5D-5L instrument.
Timepoint [5] 391518 0
Four weeks (mid-treatment) and eight weeks (post-treatment).
Secondary outcome [6] 391519 0
Bayliss measure of illness burden
Timepoint [6] 391519 0
Four weeks (mid-treatment) and eight weeks (post-treatment).
Secondary outcome [7] 391520 0
Hospital Anxiety and Depression score
Timepoint [7] 391520 0
Four weeks (mid-treatment) and eight weeks (post-treatment).
Secondary outcome [8] 391521 0
Clinical Frailty Scale
Timepoint [8] 391521 0
Four weeks (mid-treatment) and eight weeks (post-treatment).
Secondary outcome [9] 391522 0
Global perceived effect. Patients will be asked to rate perceived effectiveness on a scale of 1–9, with a score of 1 meaning much better, 5 meaning no change, and 9 meaning much worse.
Timepoint [9] 391522 0
Four weeks (mid-treatment) and eight weeks (post-treatment).
Secondary outcome [10] 391523 0
Adverse events are defined as any undesirable experience occurring during the study (regardless of whether this was related to the treatment), by the participant and will be reported by both the participant and PCHP. Adverse events or discomfort experienced by participants during this study may relate to possible side effects from performing the exercise program. During the administration of the exercise program, should a severe exacerbation of a comorbid condition arise, an ambulance will be called, and the event will be documented in the patient’s file. There is also the possibility of uncovering an unexpected medical condition during the diagnostic phase of the exercise program. Should this arise, the participant will be referred to their general medical practitioner with a letter stating the relevant findings.
Timepoint [10] 391523 0
Daily diary entries for eight weeks.
Secondary outcome [11] 392585 0
Patient satisfaction. Participant satisfaction with treatment will be measured using the numerical rating scale (NRS) (0–10), with higher scores indicating greater satisfaction.
Timepoint [11] 392585 0
Four weeks (mid-treatment) and eight weeks (post-treatment).

Eligibility
Key inclusion criteria
Inclusion Criteria (Satisfy all):
- Aged 65 years or older
- Non-specific low back pain (within the boundaries of the thoracolumbar junction to the first sacral vertebra and pelvis region)
- Presence of at least one target comorbidity; coronary heart disease, heart failure, hypertension, type 2 diabetes, obesity, chronic obstructive pulmonary disorder, and depression
- Bayliss measure of illness burden score >3 for two or more of the target comorbidities; coronary heart disease, heart failure, hypertension, type 2 diabetes, obesity, chronic obstructive pulmonary disorder, and depression
- Sufficient comprehension of the English language to understand exercise instructions
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria (Satisfy any)
- Patients with radiculopathy, evidence of nerve root compromise and / or intermittent claudication
- Diagnosis of serious pathology in the spine (such as fracture, malignancy or metastatic disease, cauda equina syndrome)
- Physiotherapy or chiropractic treatment for their low back pain in the last 6 months
- Inability to participate in treatment, e.g. due to transport problems, or unable to mobilise independently

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)
Allocation is not concealed
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The analysis will include both a descriptive analysis and qualitative evaluation. The primary outcome is to assess the feasibility of the comorbidity-adapted exercise program for older adults with low back pain and comorbid conditions. We will do this via an evaluation based of progression criteria such as trial recruitment, protocol adherence and outcome data. Mean outcome measures change scores will be calculated by subtracting the post-exercise program scores (eight weeks) from baseline scores, with standard deviation (SD) and 95% Confidence Intervals (CI) reported. All semi-structured interviews will be electronically recorded, transcribed, and imported into the NVivo data management programme (NVivo qualitative data analysis software; QSR International Pty Ltd). Transcripts will be coded to the domains of the Theoretical Domains Framework to extract the acceptability, barriers and facilitators of the exercise program. Transcripts will be coded systematically and iteratively until saturation is achieved. PCHP diaries will be reviewed to identify barriers to inform future trials.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
Date of last participant enrolment
Anticipated
4/10/2021
Actual
Date of last data collection
Anticipated
29/04/2022
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307779 0
University
Name [1] 307779 0
Macquarie University Research Seeding Grant
Country [1] 307779 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park, NSW, 2109
Country
Australia
Secondary sponsor category [1] 308488 0
None
Name [1] 308488 0
Address [1] 308488 0
Country [1] 308488 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307798 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 307798 0
Ethics committee country [1] 307798 0
Australia
Date submitted for ethics approval [1] 307798 0
12/02/2021
Approval date [1] 307798 0
Ethics approval number [1] 307798 0

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

Contacts
Principal investigator
Name 108534 0
Dr Katie de Luca
Address 108534 0
Level 3, 17 WW / C353 West
Department of Chiropractic,
Faculty of Medicine, Health and Human Sciences,
Macquarie University, NSW, 2109, Australia.
Country 108534 0
Australia
Phone 108534 0
+61 412 431 931
Fax 108534 0
Email 108534 0
katie.deluca@mq.edu.au
Contact person for public queries
Name 108535 0
Katie de Luca
Address 108535 0
Level 3, 17 WW / C353 West
Department of Chiropractic,
Faculty of Medicine, Health and Human Sciences,
Macquarie University, NSW, 2109, Australia.
Country 108535 0
Australia
Phone 108535 0
+61 412 431 931
Fax 108535 0
Email 108535 0
katie.deluca@mq.edu.au
Contact person for scientific queries
Name 108536 0
Katie de Luca
Address 108536 0
Level 3, 17 WW / C353 West
Department of Chiropractic,
Faculty of Medicine, Health and Human Sciences,
Macquarie University, NSW, 2109, Australia.
Country 108536 0
Australia
Phone 108536 0
+61 412 431 931
Fax 108536 0
Email 108536 0
katie.deluca@mq.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
This is a small (n=24), mixed methods study to test the feasibility of an exercise intervention for older adults with low back pain. Health outcome data are not the primary outcome of the study, and therefore we do not see that IPD is relevant for future sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10452Study protocol    Yet to be submitted.



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA mixed-methods feasibility study of a comorbidity-adapted exercise program for low back pain in older adults (COMEBACK): a protocol.2022https://dx.doi.org/10.1186/s40814-022-01097-x
N.B. These documents automatically identified may not have been verified by the study sponsor.