ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000773437

Ethics application status

Approved

Date submitted

27/06/2025

Date registered

22/07/2025

Date last updated

22/07/2025

Date data sharing statement initially provided

22/07/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Exercise Interventions for Mood, Physical health And Cognition, Tailored for Young Onset Dementia (The Exercise IMPACT for YOD study) - A feasibility case series

Scientific title

Exercise Interventions for Mood, Physical health And Cognition, Tailored for Young Onset Dementia (The Exercise IMPACT for YOD study) - A feasibility case series

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Young onset dementia

Condition category

Condition code

Neurological

Dementias

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will employ a case series study design, adhering to the CARE guidelines. Given limited literature examining exercise interventions for people with young onset dementia, this study will employ a case series study design to initially examine the feasibility of an 8-week exercise intervention within this population.

Participants will be asked to complete an 8-week exercise intervention, attending 2 sessions per week, with each session approximately 45 – 60 minutes in duration (Weeks 1-8). In the week prior to commencing the intervention (Week 0), participants will attend an initial consultation where the outcomes detailed below will be assessed. Participants will repeat these same outcomes following their completion of the intervention (Week 9). In addition to the post-assessment, participants will complete an interview after completing the intervention (Week 9 or 10) to gain their perceptions of the intervention.
Each intervention session (Weeks 1-8) will be a combination of resistance, aerobic, and dual tasking training that includes set, programmed exercises, as well as individualised exercises designed to achieve participant nominated goals. The intervention is designed and delivered by an accredited exercise physiologist (AEP) with several years of clinical experience.

Intervention

Setting
Participants will complete the intervention at the University of Canberra Hospital (UCH), located at the University of Canberra.

Intervention description
To mimic current models of clinical practice, exercise sessions will be delivered in a 1-on-1, face-to-face setting by an experienced Accredited Exercise Physiologist (AEP). The intervention will comprise of a total of 16 training sessions, being a combination of resistance, aerobic, and dual tasking training. The intervention will be a combination of set, programmed exercises, as well as individualised exercises designed to achieve participant nominated goals.

Each session will begin with the participant being asked a brief series of questions to identify whether they are motivated to attend and verbally consent to participating in the session. A structured warm up will follow this of approximately 5-10 minutes to increase participant’s heart rate, promote vasodilation within the skeletal muscle and reduce the potential risk of injury. Session structure will differ depending on the focus of the individual training session, however, will broadly be broken into three components: resistance training, aerobic training, and dual tasking. Participant adherence will be recorded through an attendance checklist.

During the initial screening for participation and then during the initial consultation, prospective participants will be asked how they may intend to attend the exercise sessions. For participants that may be reliant on transport services or require friends or family members to take absence from their lives to provide transport, taxi vouchers will be offered/provided to participants where needed for return travel for each session.

Resistance training
Pin-loaded machines, cable machines, and free weights allows for prescription of exercises for both upper and lower body musculature. Participants will complete a series of exercises, each for a specified number of sets and repetitions. For each exercise, the number of sets, number of repetitions, weight utilised, and perceived effort of set will be recorded. Specifically, resistance exercises will include pin loaded, free weight and cable variations to chest press, overhead press, lat pulldown, standing row, leg press, leg extension, hamstring curl, calf raises, and squats. Due to the case series nature of this intervention, exercise types (i.e. free weights, pin-loaded machines or cables) will be personalised based on participant preference.

Aerobic training
These include stationary upright bicycles, recumbent bicycles, treadmills, and ellipticals. Each of these modalities has capacity to be used, depending on the participants needs and preferences (For example, a treadmill may aggravate joint pain in those with osteoarthritis. In this instance, a low impact option will be prescribed). During aerobic training components, individuals will be aiming to maintain a heart rate between 65-85% of their maximum heart rate with the goal of inducing adaptations that improve physical fitness.

Dual tasking
Dual tasking will involve a combination of cognitive engagement, and any other modality of exercise to be completed together. When completing these tasks, the specific task will be detailed, as well as the success of completing the task, or number of correct responses.. Pending the participant's level of both cognitive and functional impairment, the cognitive engagement may range from maintaining a conversation about a topic of interest throughout the exercise, to listing objects that fit a category, e.g. types of food, to listing objects in alphabetical order, e.g. apple, banana, carrot. Another example is having different exercises at different coloured cones, and the participant must react, walk to the correct cone and complete the exercise.

Goal setting and individualised components
During the initial consultation, participant goals will be identified through goal attainment. For example a participant may enjoy bushwalking, but has particular concerns regarding balance. Depending on each session, and the goals outlined, 5-20 minutes will be allocated for goal based exercises. As such, a number of dynamic type balance exercise that are appropriate for the individual will be prescribed, such as tandem walking, balance beam walking, single leg squats/step downs, or propping. To progress these exercises, cognitive components may be included such as those mentioned above under dual tasking.

Pre-intervention assessments (Week 1)
Participants will be asked to attend the University of Canberra campus, and the University of Canberra Hospital on two occasions. During the initial consultation session, participants will be provided with a participant information form, detailing all information regarding the study and then provide informed consent prior to beginning the study. Participants will then engage in a 15-30 minute conversation detailing some aspects of medical history, current levels of physical activity and personal goals, consistent with an initial consultation conducted within an exercise physiology clinic. Following this, the participant will then complete the cardiovascular fitness assessment detailed above. During the second assessment session, participants will begin by completing the cognitive health and mood questionnaires, followed by assessments of blood pressure, grip strength, balance, and lower body strength. Participants will attend 2 pre-intervention assessment sessions that will be approximately 45-60 minutes each in duration. The total time commitment for these two assessment sessions for participants will be 2 hours.

Intervention (Week 2-9)
Participants will then be asked to attend the University of Canberra campus, and the University of Canberra Hospital twice per week for the duration of the intervention. Participants will engage in a graded, structured exercise program that includes aerobic, resistance, and dual tasking training. Each training session will be run by the lead researcher (NL), an Accredited Exercise Physiologist with experience prescribing exercise programs for people with dementia. The program will also include exercises designed to achieve specific goals that the participant has outlined in their initial consultation to individualise the program. Each training session will last 45-60 minutes in duration. The total time commitment for the intervention will be 16 hours across the eight weeks.

Post-intervention assessments (Week 10)
Identical to the pre-intervention assessments, participants will attend the University of Canberra campus, and the University of Canberra Hospital on two occasions for two assessments, where they will participate in a series of assessments regarding their physical health, cognitive health, and mood. Total time commitment for the post-intervention assessments will be 2 hours.

Timing
The expected time commitment for participants within the study will be ~21 hours of face-to-face contact.

Intervention code [1]

Lifestyle

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group due to the study being a case series

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Participant recruitment avenues

Timepoint [1]

Ongoing, duration of study recruitment

Primary outcome [2]

Participant retention

Timepoint [2]

Ongoing, throughout entire study

Primary outcome [3]

Adverse events

Timepoint [3]

Monitored and reported from week 1 (baseline assessments) to week 10 (post assessments)

Secondary outcome [1]

Fatigue - Primary outcome

Timepoint [1]

Monitored and reported from week 1 (baseline assessments) to week 10 (post assessments)

Secondary outcome [2]

Exertion

Timepoint [2]

Monitored and reported from week 1 (baseline assessments) to week 10 (post assessments)

Secondary outcome [3]

Symptoms - Primary outcome

Timepoint [3]

Monitored and reported from week 1 (baseline assessments) to week 10 (post assessments)

Secondary outcome [4]

Qualitative interviews

Timepoint [4]

At the conclusion of the study - Week 9

Secondary outcome [5]

Physical fitness

Timepoint [5]