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ISRCTN
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ISRCTN80414567
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ClinicalTrials.gov identifier
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Public title
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Cost-utility and effectiveness on health-related quality of life and fitness of a home-based exercise in the caregivers of patients with Alzheimer's disease
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Scientific title
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Acronym
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EADCA/09/05
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Serial number at source
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9/05
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Study hypothesis
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1. Home-based exercise is effective in enhancing health-related quality of life, fitness and mental health in informal caregivers
2. Home-based exercise is cost-effective in informal caregivers
3. There are differences in this effectiveness between men and women caregivers
As of 29/07/09 this record has been updated. Updates can be found in the relevant fields with the above update date. Please note that the previously listed source of funding Spanish Federation of Rare Diseases (Federación Española de Enfermedades Raras) (FEDER) was incorrect. Please also note that the end date of the trial was extended from 31/12/2007 to 31/12/2008.
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Lay summary
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Ethics approval
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Approved by the Bioethical Committee of the University of Extremadura on 12/06/2005, reference number 9/05
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Informal caregivers of Alzheimer's disease patients
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Participants - inclusion criteria
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Non-professional caregivers who have been taking care of an Alzheimer's patient for more than 20 hours per week for more than six months and are expecting to continue for 12 months more
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Participants - exclusion criteria
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1. Contraindications to physical exercise
2. Other physical therapies
3. Drugs affecting measures
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Anticipated start date
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01/07/2006
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100 caregivers (70 women and 30 men). Final number 61 women (31 intevention group) and 13 men (6 intervention group) (added 29/07/09)
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Interventions
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Current information as of 29/07/09:
9 month home-based exercise two days per week.
The control group will not receive any intervention (only the interview
and measurements). In fact, we will exclude volunteers who are following other therapies to avoid disturbances or covariables.
Information at time of registration:
One-year home-based exercise two days per week.
The control group will not receive any intervention (only the interview
and measurements). In fact, we will exclude volunteers who are following other therapies to avoid disturbances or covariables.
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Primary outcome measure(s)
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1. Stress of caregivers as assessed by the Zarit Burden interview
2. Health-related quality of life and its utilities to cost-effectiveness
3. Fitness
4. Psychological aspects (symptom checklist-90-R [SCL-90], interviews, and dimensions of health-related quality of life)
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Secondary outcome measure(s)
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1. Back pain (Roland Morris index)
2. Perceived health (visual analogue scale [VAS])
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Sources of funding
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1. Research Plan of the Health Department of Junta de Extremadura European Social Funds - (2PR04B008)
2. Sanitary Research Funds (Carlos III Institut)
3. European Funds for Development (FEDER) (European Union) (PI051601) (as of 29/07/09)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19461551
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Contact name
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Prof
Narcis
Gusi
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Address
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Faculty of Sports Sciences
Avda Universidad s/n
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City/town
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Caceres
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Zip/Postcode
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10071
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Country
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Spain
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Tel
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+34 (0)92 725 74 60
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Fax
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+34 (0)92 725 74 61
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Email
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ngusi@unex.es
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Sponsor
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University of Extremadura (Spain)
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Address
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Avda Elvas s/n
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City/town
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Badajoz
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Zip/Postcode
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06071
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Country
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Spain
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Tel
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+34 (0)92 428 93 05
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Fax
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+34 (0)92 427 29 `83
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Email
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vicein@unex.es
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Sponsor website:
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http://www.unex.es
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Date applied
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18/06/2006
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Last edited
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29/07/2009
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Date ISRCTN assigned
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14/07/2006
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