Effects of Exercise on Functional Ability in People With Dementia in Nursing Homes:a Cluster Randomised Controlled Trial

Alzheimer Disease Clinical Trial

— LEDEN  

Official title:

Effects of a Long-term Exercise Program on Functional Ability in People With Dementia Living in Nursing Homes: a Cluster Randomised Controlled Trial. The LEDEN Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444078
• Other study ID #: RC31/14/7292
• Secondary ID: 2014-A01713-44
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2017

Study information

• Verified date: August 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a cluster randomised controlled trial composed of two research arms: exercise training group (experimental group) and a social activity group (control group).

Description:

The recruitment process will be made only in NHs (Nursing Home) where the staff will have voluntarily accepted to participate in the study. We estimated to recruit 140 PWD (person with dementia) from around six-to-eight NHs (i.e., in average a minimum of 18 and a maximum of 24 PWD per NH). NHs constitute the unit of randomisation; NHs will be randomised to study groups using a 1:1 ratio (it means that all the participants living in a particular NH will participate in either the exercise training or the social activity). The randomisation will be stratified by the prevalence of dementia among NH residents; this stratification will provide homogeneity across research's arms, increasing thus the comparability among groups and producing then reliable results. Randomisation will be done by a statistician not involved in the LEDEN study. Allocation concealment will be ensured by the use opaque sealed envelopes. The randomisation list will be kept in a electronic, password-locked file matching the name of participants to their research identification number and their group allocation. Given the nature of the LEDEN intervention (exercise training, i.e., a behavioural intervention) and since the main outcome measure, i.e., participants' ability in executing ADLs, of the the study requires that the outcome assessor knows how participants cope in their daily life, LEDEN is a unblinded study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of Alzheimer's disease, vascular or mixed dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);

• MMSE = 20 (out of 30);

• living in one of the participating NHs for at least 3 months at the moment of baseline measurements (this time period will allow NH staff to have a good knowledge about the patient and about recent changes in his/her health status);

• to be able of walking at least 4 meters (with walking devices if needed but without human assistance);

• to be able to rise from a chair without help or with minimal human assistance.

Exclusion Criteria:

• Mild dementia, illustrated by a MMSE > 20 (out of 30)

• Terminal illness with life expectancy less than 6 months;

• Diagnosis of Parkinson's disease;

• Diagnosis of dementia with Lewy bodies;

• Unstable cardiovascular condition or any other health condition that might be deteriorated by physical exercise;

• Planned transfer from the NH to another NH/home or to surgery during the 6-month period of intervention;

• Already participating in physical exercise = 2 times/week in the last 2 months prior to the date of baseline assessments.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• Exercise
Exercise training will take place in the NH, twice weekly, around 60 minutes per session (session duration can be shorter during the first weeks of intervention according with participants' physical capacity), during 6 months; interval between two exercise sessions will be of at least 48 hours. The exercise program will be a multicomponent training, with exercises specifically developed to improve participants' flexibility (10 minutes), coordination and balance (10 minutes), muscle toning (10 minutes), and cardiorespiratory capacity (25 minutes). The exercise intensity targeted will be moderate. All exercise sessions will be accompanied by music.
• Social Activity
Interventionists will be health professionals external to the NH, preferentially psychologists. Interventions will take place in the NHs, at the same frequency and duration than the exercise intervention (twice weekly, 60 minutes per session, during 6 months).

Locations

Country	Name	City	State
France	Résidence d'Automne de Bruay sur Escaut	Bruay-sur-l'escaut
France	Korian Le Castelli	L'huisserie
France	Korian Pontlieue	Le Mans
France	Résidence Les Lauriers de Plaisance	Neuilly Plaisance
France	Korian Croix Périgourd	Saint Cyr Sur Loire
France	Résidence d'Automne de Notre Dame de Sanhilac	Sanilhac
France	Résidence Les Jardins de Sermaize	Sermaize-les-bains
France	Korian Vill'Alizé	Thise

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional ability	(ADL performance) as assessed by the Alzheimer Disease Cooperative Study (ADCS) ADL-sev. This is a 19-item scale measuring the ability to perform basic (e.g., bathing, toileting) and instrumental (e.g., turning faucet/lights on/off) ADLs in the last four weeks. The ADCS-ADL-sev was specifically validated for people with moderate or severe Alzheimer's disease (AD), i.e., the large majority of PWD in NHs. Scores in this scale vary from 0 to 54, with higher scores indicating better functional ability.	6th month
Secondary	Change of Functional ability	ADL performance) as assessed by the Alzheimer Disease Cooperative Study (ADCS) ADL-sev. This is a 19-item scale measuring the ability to perform basic (e.g., bathing, toileting) and instrumental (e.g., turning faucet/lights on/off) ADLs in the last four weeks. The ADCS-ADL-sev was specifically validated for people with moderate or severe Alzheimer's disease (AD), i.e., the large majority of PWD in NHs. Scores in this scale vary from 0 to 54, with higher scores indicating better functional ability.	Change and evolution at different time points: baseline, 3-month intervention, Post-intervention (6month), 3-month follow-up (9 month), 6-month follow-up (12 month)
Secondary	Physical function	as assessed by the Short Physical Performance Battery (SPPB) (score from 0 to 12).	Baseline, Post-intervention (6 month)
Secondary	Cost-effectiveness of the interventions		12 month (end of study)
Secondary	Falls and fractures		12 month (end of study)
Secondary	Cognitive function	as assessed by the Mini-Mental State Examination (MMSE).	Baseline, Post-intervention (6month)
Secondary	Behavioural and psychological symptoms of dementia (BPSD)	as assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).	Baseline, Post-intervention (6 month)
Secondary	Pain	as assessed by the Algoplus scale	Baseline, Post-intervention (6 month)
Secondary	Nutritional status	as assessed by the Mini Nutritional Assessment (MNA).	Baseline, Post-intervention (6 month)