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EHealth to empower patients with Musculoskeletal Pain in Rural Australia (EMPoweR) a randomized controlled trial.

Does a tailored physical activity program and a progressive resistance home exercise program delivered using e-Health and health coaching improves physical function in individuals with chronic low back pain and/or knee osteoarthritis who live in rural Australia compared to usual care?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001494224
Enrollment
156
Registered
2018-09-05
Start date
2019-01-18
Completion date
2021-06-08
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aim is to assess the feasibility of implementing an e-health-supported intervention comprised of a tailored physical activity plan and a progressive resistance exercise program for people living in rural Australia with chronic non-specific low back pain (LBP) and/or knee osteoarthritis (OA) in comparison to usual care. Participants allocated to the e-health intervention group (n=78), will receive a tailored physical activity and progressive resistance exercise program delivered by remote health coach consultations. Usual care participants (n=78) will receive usual care. We hypothesise that the implementation of this e-health intervention will be feasible and demonstrate preliminary efficacy.

Interventions

The intervention group will be the E-health group and the control group will be the usual care group. Participants in the e-health intervention group will receive a tailored physical activity plan and a progressive resistance exercise program designed during remote consultations with a health coach using the Physitrack® (health coach end), and Physiapp® (participant end) web applications (Physitrack® Ltd, LDN, UK). Also, their adherence and attendance rate will be electronically recorded through

The intervention group will be the E-health group and the control group will be the usual care group. Participants in the e-health intervention group will receive a tailored physical activity plan and a progressive resistance exercise program designed during remote consultations with a health coach using the Physitrack® (health coach end), and Physiapp® (participant end) web applications (Physitrack® Ltd, LDN, UK). Also, their adherence and attendance rate will be electronically recorded through this web applications, with an independent username and password for each participant. Participants will be equipped with (i) a welcome booklet with an overview of the intervention components and instructions on how to use the Physiapp® web application (Web browser, Android or iOS app) at home and (ii) an exercise kit consisting of a range of resistance bands, yoga mat, and cuff weights. The intervention will be delivered over a 3 month period and guided by a maximum total of eight remotely-delivered consultations with a health coach. The initial consultation will last one hour, while subsequent consultations will be 30 minutes. The health coach will be a qualified health professional (such as a physiotherapist, exercise physiologist, or final year physiotherapy student under supervision) with further training in an industry accredited health coaching course (for example, the combined level 1 and 2 at http://www.wellnesscoachingaustralia.com.au). During the health coach consultations, a home-exercise program will be designed according to patient preferences, individual goals, and the performance of remotely supervised exercises. The initial exercise prescription will have a dosage of 2 sets of 8-15 repetitions; 2 to 3 minute rest in between sets; up to 4 total exercises to promote early adherence; with a frequency of 3 times a week. Selected exercises will target the knee extensors and trunk musculature in both groups before further individualisation is made. After a 2 week period of familiarisation to promote early adherence, exercises will be performed to equal or greater than 5/10 (hard) on the modified Borg Rating of Perceived Exertion scale. Resistance will be provided by using body weight, resistance bands, or cuff weights to modify the difficulty of an exercise. The exercise dose used in this study is based on both the American College of Sport Medicine’s minimum recommendations for maintaining health, and previous studies using a similar intensity and frequency in non-specific chronic Low Back Pain (LBP) and knee OA populations. Modified exercises and dose will be provided for participants that are having trouble reaching this dosage initially or if, for example, muscular endurance is more appropriate. A 5-10 minute warm up and cool down will be included before and after each home exercise session focusing on joint range of motion and relaxation. Participants will be able to see the details of the exercise program, access video resources, record the details of each session and view their progress using the Physiapp® web application. Subsequent consultations will allow modification or progression of exercises if appropriate. The physical activity plan will be implemented according to the principles used in our previous study of physical activity for musculoskeletal pain. The focus of the program will be on a gradual increase in physical activity where participants will be encouraged to devise fortnightly goals to suit and advance their physical activity levels. Each health coach will be trained in the principles of health coaching to facilitate the process. The plan will be specifically tailored to each participant and will involve goal setting, monitoring, and progression of goals using the web application. The usual care provided in this trial is described as de facto usual care; this includes the wide range of care practices provided in a community which are unrestricted by study protocols or rules. This is in contrast to standardised or protocolised usual care which may not reflect the wide range of care found in the community as it may change during the conduct of the trial. Due to the nature of de facto usual care and the dual recruitment strategy used in this trial, treatments provided to participants in this group will be self-reported by using a study logbook to fill in throughout the study period. The exact treatments and care providers involved will vary depending on the participant’s location and source of recruitment. Common practice is likely to involve education, home exercises, and if within close vicinity to a health site, some additional supervised exercises tailored to the individual and may or may not involve additional manual therapy techniques. All participants who get allocated into the de facto usual care group will be provided with assistance on how to do so over the telephone and via email with a member from the research team. Participants recruited from a) Dubbo and Orange Hospital outpatient physiotherapy departments will have an appointment already scheduled and therefore will only require a reminder and instructions to continue as usual. Participants recruited from b) the general community will be asked a series of questions about the health care site they were intending to access before entering the study. Assistance will be provided to those who are unaware of what options are available in their local community with the aid of the ‘find a health service’ tool on the healthdirect website, a health service directory supported by the governments of Australia (https://www.healthdirect.gov.au/). A referral letter will then be provided to each participant and the respective health care site mutually decided upon. Costs may be incurred to participants depending on where they decide to go.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Non-specific LBP and/or knee pain lasting for at least 3 months. Participants who report both conditions will be stratified based on their primary complaint by reporting which condition concerns them the most. Pain level: LBP: Equal or greater than 3/10 on the 11-point numeric pain rating scale in the past week and knee: Equal or greater than 3/10 on the 11-point numeric pain rating scale over most days of the past month. Be in the process of seeking care through Dubbo or Orange outpatient physiotherapy department or are intending to access care (which incur costs to patients or healthcare system) in the next 3 months for their back and/or knee pain Reside in very remote, remote, inner and outer regional areas (based on the Australian Standard Geographical Classification Remoteness Area) Be fluent in English (verbal and written) Have adequate hearing and eyesight Independent ambulatory status Have current internet access and access to it at least once a month Own an internet-capable device with a display, camera, microphone and speaker (smartphone, tablet or computer). Have a self-rated ability to use the internet at-least fair (using a 4-item scale from poor, fair, good to excellent) Willingness to provide informed consent and willingness to participate and comply with the study requirements.

Exclusion criteria

Recent or imminent spinal surgery (within 12 months) Recent or imminent knee surgery (arthroscopy within 6 months; knee replacements/osteotomy within 12 months) Any recent corticosteroid injections (knee or back in the past 6 months) Evidence of radiculopathy, nerve root, spinal cord, cauda equine compression or lumbar neurogenic claudication Any known suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases, widespread neurological disorder) LBP caused by involvement in a road traffic accident in the last 12 months or ongoing litigation Have a comorbid condition that would prevent active participation in performing strengthening exercises at home or increasing physical activity levels Diagnosis of fibromyalgia or a systematic arthritic condition Current or planned pregnancy Recent fall history deemed to impose risk for potential injury

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 16, 2026