Have you or your loved ones been diagnosed with dementia?

You may be eligible to participate in a dementia clinical trial.

Have you or your loved ones been diagnosed with dementia? You may be eligible to participate in a dementia clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Dementia Clinical Trial

NCT02444078 | Interventional

Have you or your loved ones been diagnosed with dementia?

You may be eligible to participate in a dementia clinical trial.

Have you or your loved ones been diagnosed with dementia? You may be eligible to participate in a dementia clinical trial.

Completed

Male & Female

65 Years +

This study has recruited 140 Participants

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

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Details for the study

Brief Title

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

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

Brief Summary

This is a cluster randomised controlled trial composed of two research arms: exercise <br /> 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

Treatments and/or Procedures

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).

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

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)

Study Criteria

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.