NCT02444078

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 10, 2025

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

April 24, 2015

Last Update Submit

December 2, 2025

Conditions

Alzheimer DiseaseDementia

Keywords

Alzheimer DiseaseDementiaPhysical activityFunctional abilityDisabilityFunctional limitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change of 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)

  • Physical function

    Baseline, Post-intervention (6 month)

  • Cost-effectiveness of the interventions

    12 month (end of study)

  • Falls and fractures

    12 month (end of study)

  • Cognitive function

    Baseline, Post-intervention (6month)

  • +3 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Exercise sessions will be done in groups of three-to-eight persons; whilst being a group-based exercise program, participants will be guided and the exercises will be adapted in an individual basis, which may increase adherence and compliance rates.

Other: Exercise

Social activity

ACTIVE COMPARATOR

Participants in this group will participate in group-based activities such as music (percussion instruments), arts and board games; no intervention on physical activity will be provided to these participants.

Other: Social Activity

Interventions

ExerciseOTHER

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.

Exercise
Social ActivityOTHER

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).

Social activity

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Résidence d'Automne de Bruay sur Escaut

Bruay-sur-l'Escaut, 59860, France

Location

Korian Le Castelli

L'Huisserie, 53970, France

Location

Korian Pontlieue

Le Mans, 72000, France

Location

Résidence Les Lauriers de Plaisance

Neuilly-Plaisance, 93360, France

Location

Korian Croix Périgourd

Saint-Cyr-sur-Loire, 37540, France

Location

Résidence d'Automne de Notre Dame de Sanhilac

Sanilhac, 24660, France

Location

Résidence Les Jardins de Sermaize

Sermaize-les-Bains, 51531, France

Location

Korian Vill'Alizé

Thise, 25220, France

Location

Related Publications (2)

  • de Souto Barreto P, Cesari M, Denormandie P, Armaingaud D, Vellas B, Rolland Y. Exercise or Social Intervention for Nursing Home Residents with Dementia: A Pilot Randomized, Controlled Trial. J Am Geriatr Soc. 2017 Sep;65(9):E123-E129. doi: 10.1111/jgs.14947. Epub 2017 May 19.

    PMID: 28542742RESULT

  • de Souto Barreto P, Denormandie P, Lepage B, Armaingaud D, Rapp T, Chauvin P, Vellas B, Rolland Y. Effects of a long-term exercise programme on functional ability in people with dementia living in nursing homes: Research protocol of the LEDEN study, a cluster randomised controlled trial. Contemp Clin Trials. 2016 Mar;47:289-95. doi: 10.1016/j.cct.2016.02.004. Epub 2016 Feb 13.

    PMID: 26883281RESULT

MeSH Terms

Conditions

Alzheimer DiseaseDementiaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yves ROLLAND, MD

    Toulouse University Hospital (CHU Toulouse)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 14, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

December 10, 2025

Record last verified: 2022-08

Locations

FR(8)