Actively Recruiting
Adapted Physical Activity Education in Patients With Neurocognitive Disorder: Single-blind, Single-center Randomized Controlled Trial
Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-03-19
34
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Adapted Physical Activity (APA) alone versus APA combined with a physical activity education program (PAE) in patients with mild or early major neurocognitive disorders. This trial aims to see if adding education on physical activity improves physical activity levels, cognitive function, and quality of life more than APA alone. Participants will be randomly assigned to one of these two groups for comparison. Participants will attend 24 APA sessions over 12 weeks, with two one-hour sessions per week led by professionals. These sessions include exercises targeting aerobic fitness, strength, speed, balance, coordination, and flexibility, with intensity monitored by heart rate and perceived exertion. One group will also receive 8 individual 30-minute education sessions focused on setting weekly goals to increase physical activity and reduce sedentary behavior. Participants will complete three full evaluations: at the start (month 0), after 3 months of intervention (month 3), and 3 months post-intervention (month 6). Assessments include physical activity levels, cognitive and executive function tests, cardiovascular performance, muscle strength, quality of life, anxiety, depression, and apathy. These measures help researchers understand the impact of the interventions on physical and mental health over time.
CONDITIONS
Brief Title
Adapted Physical Activity Education in Patients With Neurocognitive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mild neurocognitive disorder or early major neurocognitive disorder
You will not qualify if you...
- Medical conditions that threaten short-term survival
- Moderate or severe major neurocognitive disorder (DSM 5) or MMSE score below 20
- Unbalanced depression
- Contraindications to the exercises used in the study
- Major hearing or vision impairments
- Being sufficiently active according to WHO daily recommendations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants attend adapted physical activity sessions twice weekly for 12 weeks. One group also receives weekly individual physical activity education sessions to set goals and improve activity levels.
2 sessions per week for adapted physical activity and 1 individual session per week for physical activity education (where applicable)
Duration - Up to 6 months after inclusion
Participants are assessed for physical activity level, cognition, cardiovascular performance, physical condition, quality of life, and psychological factors at 3 and 6 months after inclusion.
2 follow-up visits (at 3 months and 6 months)
Trial Site Locations
Total: 1 location
1
Nice University Hospital
Nice, France, 06000
Actively Recruiting
Research Team
J
Justine Lemaire
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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