One of the promising combined interventions is an intervention developed by Teri and colleagues. People with dementia receive an exercise program together with their caregivers. The caregivers are also trained in behaviour management techniques to…
ID
Source
Brief title
Condition
- Other condition
- Dementia and amnestic conditions
Synonym
Health condition
depressie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
People with dementia outcome measures:
• Physical health and function (SIP & SF36)
• Mood (Cornell)
We hypothesized that patients receiving the training program would improve on
these areas. We believed that these areas will show improvement only in
patients whom such problems were evident at baseline.
Secondary outcome
People with dementia outcome measure:
• Cognition (measured by neurpsycholocical research)
Caregivers:
• Physical health and functioning (GHQ-12)
• Mood (CES-D)
• Perceived pressure (SPICC, RMBPC en analyse salivary cortisol)
Background summary
People with dementia and their caregivers can suffer a lot from dementia.
Providing care to people with dementia is a heavy responsibility which can
affect the health and normal lives of family caregivers. There is no cure for
dementia, but prevention and treatment focused on behaviour problems that may
result from the dementia and the care situation is feasible. A recent review
shows that combined interventions both for people with dementia and their
caregivers were most effective to diminish depressive symptoms of people with
dementia.
Study objective
One of the promising combined interventions is an intervention developed by
Teri and colleagues. People with dementia receive an exercise program together
with their caregivers. The caregivers are also trained in behaviour management
techniques to deal with behavioural disturbances. People with dementia who
participated in the intervention program performed significantly better on
physical measures and measures of affective status compared to the usual care
group.
In our study we will translate the intervention program of Teri, adapt the
program to the Dutch situation and study whether it is feasible and effective.
We will use the same measures as in the study of Teri and add measures for
physical, cognitive and executive functioning to study the effects of the
intervention program. In addition we will study the effects of the integrated
treatment program on the mood of the family caregivers.
Study design
A randomized Controlled Trial (RCT) will be conducted. There will be
pre-measurement before randomization. The patients-caregivers dyads will be
randomly assigned to the training program or care-as-usual with attention. The
duration of the exercise training is three months. The intervention effect will
be assessed by trained interviewers blind to the treatment assignment.
Assessments are conducted at screening baseline, after 3 months (posttreatment)
and at 6, and 12-month follow-up.
Intervention
The goal of the exercise training program is that people with dementia will
exercise actively during at least 30 minutes a day. The exercises will include
balance, strength training, aerobic/endurance activities and flexibility
training.
In addition the caregiver will learn how to cope with the demented person, will
be advised in dementia and the consequences and pleasure activities with the
patient will be stimulated.
The patient-caregiver dyads will be visited in their own homes by trained
students for 12 hour-long sessions during a schedule of 2 sessions per week
during the first 3 weeks, followed by weekly sessions during 4 weeks, and then
biweekly sessions over the next 4 weeks. In these sessions the trained students
will explain the exercise program and train the caregivers in behaviour
management techniques to deal with behavioural disturbances.
Study burden and risks
All research will be conducted at the residence of the participants
People with dementia:
- Analyse APOE4 via wangslijmvlies: 1 time
- Analyse heart-rate & blood pressure: 3-4 times
- analyse slaap-waakritme middels actiwatches om de pols gedurende 24 uur: 3-4
times
- Neuro Psychological Research: 3-4 times
- Questionnaires (all questionnaires will be completed by the interviewer):
Medical Outcome Study Short Form Health Survey (SF-36)
Sickness Impact Profile (SIP)
Cornell scale for Depression in Dementia
Hamilton Depression Rating Scale
Caregivers:
- Analyse salivary cortisol: 3-4 times (Cortisol will be assessed by sampling
saliva at the time of awakening and within the first 30 minutes after awakening)
- Questionnaires:
General Health Question-12 (GHQ-12)
Centre for Epidemiologic Studies-Depression (CES-D)
Perceived Pressure from Informal Care (SPPIC)
RMBPC: perceived stress
Confidential information and patient names are treated according to the medical
confidentiality rules.
Van der Boechortsstraat 1
1081 BT Amsterdam
NL
Van der Boechortsstraat 1
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for people with dementia are:
- people with dementia (Alzheimer Disease, Lewy Bodies, Vascular Dementia, Frontotemporal Dementia etc.)
- minimum age 55 years
- living at home and not institutionalized,
- to have caregivers willing to participate in the training sessions, and
- written informed consent (caregivers provide consent on behalf of the people with AD).
- be able to keep balance and to walk some steps without help;Inclusion criteria for the caregivers are:
- to be spouses or adult relatives who live with, or spent a minimum of 4 hours every day with the patient,
- minimum age 25 years,
- be able to give instructions to the patient,
- 5 or more points on CES-D
- to have enough understanding of the Dutch language,
- written informed consent.
Exclusion criteria
Exclusion criteria for people with dementia are:
- use of antidepressants
- MMSE < 14
- presence of psychotic symptoms or cerebral trauma
- receive more than two days outpatients* care. ;Exclusion criteria for the caregivers are:
- physical difficulties (not possible to assist the participant with the exercises)
- presence of psychotic symptoms
- use of antidepressants.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26088.029.08 |