Alzheimer DiseaseLEDENNCT02444078
Effects of Exercise on Functional Ability in People With Dementia in Nursing Homes:a Cluster Randomised Controlled Trial
A study testing Exercise and Social Activity in people with Alzheimer Disease and Dementia, run by University Hospital, Toulouse at 8 sites in France.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Exercise and Social Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 8 sitesFrance
- Study dates
- Aug 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Résidence d'Automne de Bruay sur Escaut
Bruay-sur-l'Escaut, 59860
Korian Le Castelli
L'Huisserie, 53970
Korian Pontlieue
Le Mans, 72000
Résidence Les Lauriers de Plaisance
Neuilly-Plaisance, 93360
Korian Croix Périgourd
Saint-Cyr-sur-Loire, 37540
Résidence d'Automne de Notre Dame de Sanhilac
Sanilhac, 24660
Résidence Les Jardins de Sermaize
Sermaize-les-Bains, 51531
Korian Vill'Alizé
Thise, 25220
About this study
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
This is a cluster randomised controlled trial composed of two research arms: exercise training group (experimental group) and a social activity group (control group).
Read the detailed 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
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Exercise, Social Activity
- Keywords
- Alzheimer Disease, Dementia, Physical activity, Functional ability, Disability, Functional limitation
- Medical subject headings
- Alzheimer Disease, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Social Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6th month
Secondary outcomes (8)
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.
Measured: 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
as assessed by the Short Physical Performance Battery (SPPB) (score from 0 to 12).
Measured: Baseline, Post-intervention (6 month)
Cost-effectiveness of the interventions
Measured: 12 month (end of study)
Falls and fractures
Measured: 12 month (end of study)
Cognitive function
as assessed by the Mini-Mental State Examination (MMSE).
Measured: Baseline, Post-intervention (6month)
Behavioural and psychological symptoms of dementia (BPSD)
as assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).
Measured: Baseline, Post-intervention (6 month)
Pain
as assessed by the Algoplus scale
Measured: Baseline, Post-intervention (6 month)
Nutritional status
as assessed by the Mini Nutritional Assessment (MNA).
Measured: Baseline, Post-intervention (6 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves ROLLAND, MD, Principal investigator, Toulouse University Hospital (CHU Toulouse)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444078
- Sponsor's protocol ID
- RC31/14/7292
- Other IDs
- 2014-A01713-44
- Acronym
- LEDEN
- Status last verified
- Aug 2022
- First submitted
- 24 Apr 2015
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28542742de 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.
PubMed 26883281
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02444078
- Acronym / sponsor ID
- LEDEN / RC31/14/7292
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Alzheimer Disease, Dementia, Physical activity, Functional ability, Disability, Functional limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cluster randomised controlled trial composed of two research arms: exercise training group (experimental group) and a social activity group (control group).
Detailed 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseExercise 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. |
| Social activity | Active comparator | Other: Social ActivityParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise 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. | Other | Exercise |
| Social ActivityInterventionists 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). | Other | Social activity |
Primary outcome
Functional ability
Time frame: 6th month
(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.
8 secondary outcomes
Change of Functional ability
Time frame: 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
Time frame: Baseline, Post-intervention (6 month)
Cost-effectiveness of the interventions
Time frame: 12 month (end of study)
Falls and fractures
Time frame: 12 month (end of study)
Cognitive function
Time frame: Baseline, Post-intervention (6month)
Behavioural and psychological symptoms of dementia (BPSD)
Time frame: Baseline, Post-intervention (6 month)
Pain
Time frame: Baseline, Post-intervention (6 month)
Nutritional status
Time frame: Baseline, Post-intervention (6 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 28542742de 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.
- Results publication: PubMed 26883281de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves ROLLAND, MD principal investigator
Toulouse University Hospital (CHU Toulouse)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Social Activity in people with Alzheimer Disease and Dementia, run by University Hospital, Toulouse at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional ability (time frame: 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444078, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.