Condition category
Nervous System Diseases
Date applied
18/06/2006
Date assigned
14/07/2006
Last edited
29/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.unex.es

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19461551

Publication citations

  1. 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.

Additional files

Editorial Notes