EduAPA: Adapted Physical Activity Education in Patients With Neurocognitive Disorder

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05866822

Collaborator

(none)

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to compare the effect of a program of Adapted Physical Activity (APA) versus the same program combined with a physical activity education program (PAE). Patients suffering from neurocognitive disorders (mild or early major) will be randomized into one of the two conditions. 3 complete evaluations will be done (inclusion M0, after 3 month of intervention M3, 3 months after the end of the intervention M6). The team except that APA+PEA will be more effectiv than the APA solely, on the following criteria : level of physical activity, cogntive function and quality of life.

Condition or Disease	Intervention/Treatment	Phase
Neurocognitive Disorders	Other: APA Other: PAE	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Adapted Physical Activity Education in Patients With Neurocognitive Disorder: Single-blind, Single-center Randomized Controlled Trial

Anticipated Study Start Date :

May 20, 2023

Anticipated Primary Completion Date :

Nov 20, 2023

Anticipated Study Completion Date :

Nov 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: APA (adapted physical activity) 24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor,	Other: APA 24 APA sessions
Experimental: APA (adapted physical activity) + physical activity education (PAE) 24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor, + 8 individuals sessions of PAE (one per week, half an hour long) that will consist of advising and setting weekly goals related to improving PA level and sedentary behavior	Other: APA 24 APA sessions Other: PAE 8 individuals sessions of PAE

Arm

Intervention/Treatment

Active Comparator: APA (adapted physical activity)

24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor,

Other: APA

24 APA sessions

Experimental: APA (adapted physical activity) + physical activity education (PAE)

Other: APA

24 APA sessions

Other: PAE

8 individuals sessions of PAE

Outcome Measures

Primary Outcome Measures

physical activity level [at inclusion]
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
physical activity level [at 3 months after inclusion]
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
physical activity level [at 6 months after inclusion]
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score

Secondary Outcome Measures

global cognition [at inclusion]
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
global cognition [at 3 months after inclusion]
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
global cognition [at 6 months after inclusion]
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
executive functions [at inclusion]
executiv functions will be assessed by FAB (frontal assessment battery)
executive functions [at 3 months after inclusion]
executiv functions will be assessed by FAB (frontal assessment battery)
executive functions [at 6 months after inclusion]
executiv functions will be assessed by FAB (frontal assessment battery)
executive functions (FAB) [at inclusion]
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
executive functions (FAB) [at 3 months after inclusion]
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
executive functions (FAB) [at 6 months after inclusion]
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
executive functions (TMT) [at inclusion]
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
executive functions (TMT) [at 3 months after inclusion]
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
executive functions (TMT) [at 6 months after inclusion]
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
cardiovascular performance [at inclusion]
Cardiovascular performance will be evaluated through a effort test that will be performed on a stationary bicycle ergometer connected to a portable gas exchange analysis system in ml/kg/min
cardiovascular performance [at 3 months after inclusion]
Cardiovascular performance will be evaluated through a effort test that will be performed on a stationary bicycle ergometer connected to a portable gas exchange analysis system in ml/kg/min
cardiovascular performance [at 6 months after inclusion]
Cardiovascular performance will be evaluated through a effort test that will be performed on a stationary bicycle ergometer connected to a portable gas exchange analysis system in ml/kg/min
power - physical condition [at inclusion]
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
power - physical condition [at 3 months after inclusion]
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
power - physical condition [at 6 months after inclusion]
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
strenght - physical condition [at inclusion]
physical condition will be asessed by grip strength (hand grip) with a score
strenght - physical condition [at 3 months after inclusion]
physical condition will be asessed by grip strength (hand grip) with a score
strenght - physical condition [at 6 months after inclusion]
physical condition will be asessed by grip strength (hand grip) with a score
evaluation of quality of life [at inclusion]
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
evaluation of quality of life [at 3 months after inclusion]
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
evaluation of quality of life [at 6 months after inclusion]
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
anxiety and depression [at inclusion]
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
anxiety and depression [at 3 months after inclusion]
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
anxiety and depression [at 6 months after inclusion]
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
apathy [at inclusion]
apathy will be assessed by the apathy inventory questionnary and givig a score
apathy [at 3 months after inclusion]
apathy will be assessed by the apathy inventory questionnary and givig a score
apathy [at 6 months after inclusion]
apathy will be assessed by the apathy inventory questionnary and givig a score

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

mild neurocognitive disorder or early major neurocognitive disorder

Exclusion Criteria:

Medical pathology involving the vital prognosis in the short term
Major neurocognitive disorder at moderate stage and beyond (DSM 5) and/or MMSE < 20
Unbalanced depressive syndrom
Contraindication to the practice of the exercises proposed during the study;
Major hearing or visual impairment;
Sufficiently active with regard to the daily recommendations described by the WHO

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nice University Hospital	Nice		France	06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT05866822

Other Study ID Numbers:

21-AOI-10

First Posted:

May 19, 2023

Last Update Posted:

May 19, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neurocognitive Disorders

Study Results

No Results Posted as of May 19, 2023