Contact information
Type
Scientific
Primary contact
Prof Narcis Gusi
ORCID ID
Contact details
Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain
+34 (0)92 725 74 60
ngusi@unex.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9/05
Study information
Scientific title
Acronym
EADCA/09/05
Study hypothesis
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.
Ethics approval
Approved by the Bioethical Committee of the University of Extremadura on 12/06/2005, reference number 9/05
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Informal caregivers of Alzheimer's disease patients
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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)
Secondary outcome measures
1. Back pain (Roland Morris index)
2. Perceived health (visual analogue scale [VAS])
Overall trial start date
01/07/2006
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 caregivers (70 women and 30 men). Final number 61 women (31 intevention group) and 13 men (6 intervention group) (added 29/07/09)
Participant exclusion criteria
1. Contraindications to physical exercise
2. Other physical therapies
3. Drugs affecting measures
Recruitment start date
01/07/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Spain
Trial participating centre
Faculty of Sports Sciences
Caceres
10071
Spain
Sponsor information
Organisation
University of Extremadura (Spain)
Sponsor details
Avda Elvas s/n
Badajoz
06071
Spain
+34 (0)92 428 93 05
vicein@unex.es
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Research Plan of the Health Department of Junta de Extremadura European Social Funds - (2PR04B008)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanitary Research Funds (Carlos III Institut)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European Funds for Development (FEDER) (European Union) (PI051601) (as of 29/07/09)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19461551
Publication citations
-
Results
Gusi N, Prieto J, Madruga M, Garcia JM, Gonzalez-Guerrero JL, Health-related quality of life and fitness of the caregiver of patient with dementia., Med Sci Sports Exerc, 2009, 41, 6, 1182-1187, doi: 10.1249/MSS.0b013e3181951314.