Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000853448
Ethics application status
Approved
Date submitted
17/07/2025
Date registered
7/08/2025
Date last updated
7/08/2025
Date data sharing statement initially provided
7/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Exercise Prescription and Adherence for Type 2 Diabetes Management for Adults with Long-COVID
Scientific title
Enhancing Exercise Prescription and Adherence for Type 2 Diabetes Management for Adults with Long-COVID: A Pilot Trial
Secondary ID [1] 309211 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 329354 0
Long COVID 329355 0
Condition category
Condition code
Metabolic and Endocrine 326298 326298 0 0
Diabetes
Respiratory 326303 326303 0 0
Other respiratory disorders / diseases
Infection 334667 334667 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Potential participants will initially make contact via email or phone if they are willing to volunteer to take part in the study. Potential participants will initially be screened to ensure they meet all eligibility criteria. After providing written informed consent, the participants will undergo one in-person assessment at the Hunter Medical Research Institute (~3 hours).

The intervention group will undergo an 8-week exercise program, delivered in groups of 2-6 by an Accredited Exercise Physiologist. Participants will complete one 1-hour session per week, which will include 45 minutes of exercise and 15 minutes of education. Participants will be provided with an individualised home program to complete twice weekly, outside of the supervised sessions. The exercise sessions will include aerobic and resistance training, targeting all major muscle groups using body weight (e.g., wall push-ups), free weight (e.g., dumbbell bicep curl), and machine-based exercise (e.g., leg press). The exercise intensity will be prescribed based on long-COVID symptoms. The aim will be to achieve a Borg 0-10 category ratio dyspnoea or fatigue score of 4 to 6 (somewhat severe to severe). Exercise will be modified based on symptom responses to enable participants to exercise for high enough volumes and intensities to achieve physiological adaptations, without exacerbating unpleasant long-COVID symptoms. Exercises will be progressed on as as-needed basis. Adherence will be monitored through attendance checklists.

In addition to the structured exercise component, the program will also include 15 minutes of education to help participants transition to self-management. These will be delivered by electronic slide presentations at the end of each session, and will cover such topics as safe intensity of movement, how to self-monitor symptoms and prevent activity-related symptom exacerbations, health behaviour change, exercise guidelines for T2D, goal setting, medications, and dietary guidelines. To enhance the likelihood of long-term behaviour change, the education sessions will target key constructs from Bandura’s Social Cognitive Theory (i.e., self-efficacy, goals, beliefs, and social support). The education has been specifically designed for this program.

After the 8-week program, participants will attend the Hunter Medical Research Institute for their follow-up assessment (~3 hours).
Intervention code [1] 325657 0
Lifestyle
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334167 0
Feasibility of a symptom-guided exercise intervention (recruitment rate, retention rate, reasons for attrition, participant acceptability, practicality). This will be assessed via audits of study records, attendance lists, and semi-structured, individual interviews at the conclusion of the program. Feasibility will be considered as composite.
Timepoint [1] 334167 0
The total duration of the study will be 10 weeks – this includes one baseline assessment visit in week 1, eight weeks of supervised telehealth-delivered exercise in weeks 2-9, and one final assessment visit in week 10
Secondary outcome [1] 419626 0
Glycated haemoglobin (HbA1c; blood test)
Timepoint [1] 419626 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [2] 419627 0
Fasting blood glucose (blood test)
Timepoint [2] 419627 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [3] 419628 0
Cholesterol profile (blood test)
Timepoint [3] 419628 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [4] 419629 0
Fasting insulin (blood test)
Timepoint [4] 419629 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [5] 419630 0
Glycaemic control - percentage time in normal range (continuous glucose monitor worn for 14 days)
Timepoint [5] 419630 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [6] 419631 0
Pulmonary function (spirometry)
Timepoint [6] 419631 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [7] 419632 0
Vascular health (pulse wave analysis using SphygmoCor XCel)
Timepoint [7] 419632 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [8] 419633 0
Cardiorespiratory fitness (VO2peak assessed on a cycle ergometer)
Timepoint [8] 419633 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [9] 419634 0
Body composition (Lean tissue mass via DXA)
Timepoint [9] 419634 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [10] 419635 0
Muscular strength (grip strength via dynamometer)
Timepoint [10] 419635 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [11] 419636 0
Physical activity levels (International Physical Activity Questionnaire)
Timepoint [11] 419636 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [12] 419637 0
Long-COVID symptom burden (COVID-19 Yorkshire Rehabilitation Scale))
Timepoint [12] 419637 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [13] 419638 0
Health-related quality of life (Diabetes Distress Scale)
Timepoint [13] 419638 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [14] 419639 0
Safety - the type, incidence, and severity of adverse events will be determined based on the Common Terminology Criteria for Adverse Events. Examples include delayed onset muscle soreness (DOMS), drop in blood glucose, hypotension.
Timepoint [14] 419639 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [15] 419640 0
Diet (24 hour recall)
Timepoint [15] 419640 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [16] 450384 0
Glycaemic control - average 24hr glucose (continuous glucose monitor worn for 14 days)
Timepoint [16] 450384 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [17] 450385 0
Glycaemic control - glucose variability (continuous glucose monitor worn for 14 days)
Timepoint [17] 450385 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [18] 450386 0
Pulmonary function (diffusing capacity of the lungs for carbon monoxide)
Timepoint [18] 450386 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [19] 450387 0
Pulmonary function (lung volumes via body plethysmography)
Timepoint [19] 450387 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [20] 450388 0
Vascular health (pulse wave velocity via SphygmoCor Xcel)
Timepoint [20] 450388 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [21] 450389 0
Body composition (Body fat mass via DXA)
Timepoint [21] 450389 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [22] 450390 0
Body composition (Body fat percentage via DXA)
Timepoint [22] 450390 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [23] 450391 0
Body composition (Bone mineral content via DXA)
Timepoint [23] 450391 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [24] 450392 0
Body composition (waist and hip girths via tape measure)
Timepoint [24] 450392 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [25] 450395 0
Muscular strength (30sec sit-to-stand test)
Timepoint [25] 450395 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [26] 450396 0
Physical activity levels (Accelerometry for 14 days)
Timepoint [26] 450396 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [27] 450397 0
Long-COVID symptom burden (University of California, San Diego Shortness of Breath Questionnaire)
Timepoint [27] 450397 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).
Secondary outcome [28] 450398 0
Long-COVID symptom burden (Fatigue Severity Scale)
Timepoint [28] 450398 0
Participants will be assessed before and after the 8-week intervention (week 10 post-enrolment).

Eligibility
Key inclusion criteria
Adults over the age of 18 years diagnosed with type 2 diabetes who are experiencing long-COVID symptoms that reduce exercise tolerance (determined as a modified Medical Research Council dyspnoea score of or over 1 and/or fatigue that was not present pre-COVID; >12 weeks following confirmed SARS-CoV-19 infection).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be ineligible if they have any condition as per the absolute contraindications to exercise outlined by the American College of Sports Medicine including, but not limited to: unstable angina; recent (within the past four weeks) myocardial infarction; coronary artery disease; uncompensated heart failure; New York Heart Association functional classification II-IV; severe valvular illness; pulmonary disease; uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg); renal failure (chronic kidney disease stages IV-V); cardiomyopathy. People will also be ineligible for: having type 1 diabetes, not being able to complete pre-COVID-19 activities of daily living and occupation within tolerable symptom limits, meeting the physical activity guidelines (150minutes/week moderate intensity or 75minutes/week vigorous intensity exercise), planned medical operations during the research period, a physical condition whereby exercise training would be inappropriate, pregnant or expecting to be pregnant during the study period, and non-English speaking.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313399 0
Charities/Societies/Foundations
Name [1] 313399 0
Diabetes Australia
Country [1] 313399 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
School of Environmental and Life SciencesUniversity of Newcastle10 Chittaway RoadOurimbah NSW 2258
Country
Australia
Secondary sponsor category [1] 315166 0
None
Name [1] 315166 0
NA
Address [1] 315166 0
NA
Country [1] 315166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312618 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 312618 0
Ethics committee country [1] 312618 0
Australia
Date submitted for ethics approval [1] 312618 0
30/01/2023
Approval date [1] 312618 0
10/02/2023
Ethics approval number [1] 312618 0

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

Contacts
Principal investigator
Name 125302 0
Dr Emily Cox
Address 125302 0
School of Environmental and Life SciencesUniversity of Newcastle10 Chittaway RoadOurimbah NSW 2258
Country 125302 0
Australia
Phone 125302 0
+61 2 4985 4515
Fax 125302 0
Email 125302 0
[email protected]
Contact person for public queries
Name 125303 0
Emily Cox
Address 125303 0
School of Environmental and Life SciencesUniversity of Newcastle10 Chittaway RoadOurimbah NSW 2258
Country 125303 0
Australia
Phone 125303 0
+61 2 4985 4515
Fax 125303 0
Email 125303 0
[email protected]
Contact person for scientific queries
Name 125304 0
Emily Cox
Address 125304 0
School of Environmental and Life SciencesUniversity of Newcastle10 Chittaway RoadOurimbah NSW 2258
Country 125304 0
Australia
Phone 125304 0
+61 2 4985 4515
Fax 125304 0
Email 125304 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• All of the individual participant data collected during the trial in a non-identifiable form. If the participant has given extended consent, group mean and standard deviations for all outcome data will be shared on request to the PI. For example for the purpose of meta analysis where data not reported in suitable format in the publication.

Data that will be shared are clinical outcome data.

What types of analyses could be done with individual participant data?
• Meta-analysis or other pooled analysis of raw data. All data to be shared will be de-identified.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Email trial PI - [email protected]

Are there extra considerations when requesting access to 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.