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

ISRCTN	ISRCTN80414567
DOI	https://doi.org/10.1186/ISRCTN80414567
Secondary identifying numbers	9/05

Submission date: 18/06/2006
Registration date: 14/07/2006
Last edited: 03/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Narcis Gusi
Scientific

Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain

Phone	+34 (0)92 725 74 60
Email	ngusi@unex.es

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title	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
Study acronym	EADCA/09/05
Study objectives	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(s)	Approved by the Bioethical Committee of the University of Extremadura on 12/06/2005, reference number 9/05
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2006
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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)
Total final enrolment	48
Key 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
Key exclusion criteria	1. Contraindications to physical exercise 2. Other physical therapies 3. Drugs affecting measures
Date of first enrolment	01/07/2006
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Spain

Study participating centre

Faculty of Sports Sciences

Caceres
10071
Spain

Sponsor information

University of Extremadura (Spain)
University/education

Avda Elvas s/n
Badajoz
06071
Spain

Phone	+34 (0)92 428 93 05
Email	vicein@unex.es
Website	http://www.unex.es
"ROR"	https://ror.org/0174shg90

Funders

Funder type

Government

Research Plan of the Health Department of Junta de Extremadura European Social Funds - (2PR04B008)

No information available

Sanitary Research Funds (Carlos III Institut)

No information available

European Funds for Development (FEDER) (European Union) (PI051601) (as of 29/07/09)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No
Results article		07/09/2020	03/11/2021	Yes	No

Editorial Notes

03/11/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.