Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000941369p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
1/07/2026
Date registered
Help: Date registered
30/07/2026
Date last updated
Help: Date last updated
30/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The RECOVER Trial: Restoring Energy and Capacity in Older adults via aged care Embedded Rehabilitation
Scientific title
The RECOVER Trial: Evaluating the Effectiveness and Implementation of Restoring Energy and Capacity in Older adults via aged care Embedded Rehabilitation
Additional trial identifiers [1] 317766 0
APP2046840
Universal Trial Number (UTN)
Trial acronym
RECOVER (Restoring Energy and Capacity in Older adults via aged care Embedded Rehabilitation)
Related trial records

Health condition
Health condition(s) studied:
Long COVID 342667 0
Post-viral illness 342668 0
Respiratory Syncytial Virus (RSV) 342970 0
Influenza 342971 0
Functional decline 342972 0
Condition category
Condition code
Physical Medicine / Rehabilitation 338804 338804 0 0
Other physical medicine / rehabilitation
Public Health 338805 338805 0 0
Health service research
Infection 339079 339079 0 0
Other infectious diseases
Respiratory 339154 339154 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Rehabilitation and recovery program designed for frail older people with post-viral illness symptoms and/or functional decline. The program is underpinned by frailty guidelines, rehabilitation guidelines for long COVID and our consultation with consumers regarding a preferred model of care. The intervention includes comprehensive assessment and care planning by an allied health professional, nurse or allied health student (1 consultation). The comprehensive assessment will include an assessment of the person's symptoms, frailty, level of function and goals for recovery. This will be followed by optional referral to other health professions as needed (counselling, specialist, dietitian, pharmacist). A short goal-orientated program will be offered twice weekly over 8 weeks by an allied health professional, nurse, allied health assistant or allied health student or careworker (16 consultations). This program will involve completion of appropriate prescribed exercises and activities designed to build strength, endurance and capacity while avoiding post exertional malaise. The person will also receive personalised education and support with fatigue management (using the principles of planning, pacing, and prioritising and applying these to the person's daily routines) by an allied health professional, nurse or allied health student (1 consultation) followed by final review whereby the person's function, symptoms and goal attainment are reviewed (1 consultation). Therefore the intervention will involve a total of 19 consultations plus referrals to other disciplines as required. Consultations are expected to last for a duration of approximately 30-60 minutes.
The program will be delivered by a combination of allied health professionals/nurses/allied health students and allied health assistants/careworkers.
The program will be offered to individuals either in person or online in individual consultations. For online programs, the participant will be emailed a meeting invitation to join via an online platform. (It will be offered in the person's residence (private home for community dwelling older people and residential care home for residents of aged care homes).
Adherence and fidelity will be measured using interventionist records and a fidelity checklist.
Intervention code [1] 334606 0
Rehabilitation
Intervention code [2] 334857 0
Treatment: Other
Description of the comparator or control
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346002 0
Change in Physical Component Summary score of the SF36
Timepoint [1] 346002 0
Baseline, post intervention (8 weeks, primary timepoint), 16 weeks
Secondary outcome [1] 464108 0
Barthel Index
Timepoint [1] 464108 0
Baseline, post intervention (8 weeks), 16 weeks
Secondary outcome [2] 464109 0
5 time Sit to Stand
Timepoint [2] 464109 0
Baseline, post intervention (8 weeks)
Secondary outcome [3] 464111 0
Clinical Frailty Scale
Timepoint [3] 464111 0
Baseline, post intervention (8 weeks)
Secondary outcome [4] 464113 0
DePaul Symptom Questionnaire Post-Exertional Malaise 2
Timepoint [4] 464113 0
Baseline, post intervention (8 weeks)
Secondary outcome [5] 464114 0
Health related quality of life measured using the SF6D
Timepoint [5] 464114 0
Baseline, post intervention (8 weeks)
Secondary outcome [6] 464117 0
Modified COVID-19 Yorkshire Rehabilitation Scale
Timepoint [6] 464117 0
Baseline, post intervention (8 weeks)
Secondary outcome [7] 464118 0
Adverse events
Timepoint [7] 464118 0
Baseline, post intervention (8 weeks)

Eligibility
Key inclusion criteria
Older person receiving aged care services through partner organisations (residential or home-based care through Support at Home or Commonwealth Home Support).
Frail, determined using the Clinical Frailty Scale with a score of 5-7.
Recent history of viral illness (long COVID, Respiratory Syncytial Virus (RSV), influenza, gastroenteritis) identified through self-report, test, or clinical assessment. The World Health Organization’s COVID-19 case definitions of ‘suspected’, ‘probable’, or ‘confirmed’ infection will be used. Where applicable, testing would be via an antigen test which tests for COVID-19, RSV, and Influenza A&B (e.g., Covid-19/RSV/Influenza A&B Antigen Test).
Persistent symptoms (physical or cognitive fatigue) and/or functional decline (has not recovered to usual level of independence in daily activities) at 4 weeks (and up to 12 weeks) post-illness onset identified through care provider records or older person self-report.
Participants must have sufficient cognitive ability to be able to participate in the intervention (e.g. understand and follow simple instructions). This will be determined with a score of <10 using the PAS Subject Interview.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Score of >10 using the PAS Subject interview tool.
Disruptive behaviours untenable for supervised exercise (e.g., agitation which causes distress to self or others) as documented in care provider data.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
30/04/2028
Actual
Date of last data collection
Anticipated
31/08/2028
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA

Funding & Sponsors
Funding source category [1] 322304 0
Government body
Name [1] 322304 0
Department of Health, Disability and Ageing - Medical Research Future Fund
Country [1] 322304 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 325223 0
University
Name [1] 325223 0
University of Sydney
Address [1] 325223 0
Country [1] 325223 0
Australia
Secondary sponsor category [2] 325224 0
University
Name [2] 325224 0
Southern Adelaide Local Health Network
Address [2] 325224 0
Country [2] 325224 0
Australia
Secondary sponsor category [3] 325225 0
University
Name [3] 325225 0
SAHMRI
Address [3] 325225 0
Country [3] 325225 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320814 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 320814 0
Ethics committee country [1] 320814 0
Australia
Date submitted for ethics approval [1] 320814 0
03/07/2026
Approval date [1] 320814 0
Ethics approval number [1] 320814 0

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

Contacts
Principal investigator
Name 151730 0
Prof Kate Laver
Address 151730 0
Flinders University, Flinders Drive, Bedford Park, 5042, South Australia
Country 151730 0
Australia
Phone 151730 0
+61 8 7221 8335
Fax 151730 0
Email 151730 0
[email protected]
Contact person for public queries
Name 151731 0
Kate Laver
Address 151731 0
Flinders University, Flinders Drive, Bedford Park, 5042, South Australia
Country 151731 0
Australia
Phone 151731 0
+61 8 7221 8335
Fax 151731 0
Email 151731 0
[email protected]
Contact person for scientific queries
Name 151732 0
Kate Laver
Address 151732 0
Flinders University, Flinders Drive, Bedford Park, 5042, South Australia
Country 151732 0
Australia
Phone 151732 0
+61 8 7221 8335
Fax 151732 0
Email 151732 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.