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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]

None

Universal Trial Number (UTN)

Trial acronym

COME-BACK

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low Back Pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Patient recruitment

Timepoint [1]

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]

Retention

Timepoint [2]

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]

Intervention adherence

Timepoint [3]

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]

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]

12 weeks post-commencement of the intervention.

Secondary outcome [2]

The 6-minute walk test will be carried out by patients on a 30 m walkway to assess aerobic capacity and endurance.

Timepoint [2]

Four weeks (mid-treatment) and eight weeks (post-treatment).

Secondary outcome [3]

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]

SMS daily for eight weeks

Secondary outcome [4]

Oswestry Disability Index

Timepoint [4]

Four weeks (mid-treatment) and eight weeks (post-treatment).

Secondary outcome [5]

Health-related quality of life will be measured using the EQ-5D-5L instrument.

Timepoint [5]

Four weeks (mid-treatment) and eight weeks (post-treatment).

Secondary outcome [6]

Bayliss measure of illness burden

Timepoint [6]

Four weeks (mid-treatment) and eight weeks (post-treatment).

Secondary outcome [7]

Hospital Anxiety and Depression score

Timepoint [7]

Four weeks (mid-treatment) and eight weeks (post-treatment).

Secondary outcome [8]

Clinical Frailty Scale

Timepoint [8]

Four weeks (mid-treatment) and eight weeks (post-treatment).

Secondary outcome [9]

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]

Four weeks (mid-treatment) and eight weeks (post-treatment).

Secondary outcome [10]

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]

Daily diary entries for eight weeks.

Secondary outcome [11]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University Research Seeding Grant

Address [1]

Balaclava Rd, Macquarie Park, NSW, 2109

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Balaclava Rd, Macquarie Park, NSW, 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee

Ethics committee address [1]

Balaclava Rd, Macquarie Park, NSW, 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/02/2021

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Low back pain is common, with the prevalence of low back pain increasing across the lifespan where it has a profound impact on physical and psychosocial health. Also, with increasing age comes increasing comorbidity and this also has pronounced health consequences. While exercise is beneficial for a range of health conditions, trials of low back pain and exercise often exclude older adults. This mixed methods study will assess the feasibility of an eight-week comorbidity-adapted exercise program for older people with low back pain and comorbid conditions.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Katie de Luca

Address

Level 3, 17 WW / C353 West
Department of Chiropractic,
Faculty of Medicine, Health and Human Sciences,
Macquarie University, NSW, 2109, Australia.

Country

Australia

Phone

+61 412 431 931

Fax

[email protected]

Contact person for public queries

Name

Katie de Luca

Address

Level 3, 17 WW / C353 West
Department of Chiropractic,
Faculty of Medicine, Health and Human Sciences,
Macquarie University, NSW, 2109, Australia.

Country

Australia

Phone

+61 412 431 931

Fax

[email protected]

Contact person for scientific queries

Name

Katie de Luca

Address

Level 3, 17 WW / C353 West
Department of Chiropractic,
Faculty of Medicine, Health and Human Sciences,
Macquarie University, NSW, 2109, Australia.

Country

Australia

Phone

+61 412 431 931

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
10452	Study 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

Source	Title	Year of Publication	DOI
Embase	A mixed-methods feasibility study of a comorbidity-adapted exercise program for low back pain in older adults (COMEBACK): a protocol.	2022	https://dx.doi.org/10.1186/s40814-022-01097-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically