Condition category
Not Applicable
Date applied
28/04/2020
Date assigned
02/06/2020
Last edited
21/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Female family members, typically spouses or daughters, who are responsible for taking care of patients with dementia in the majority of cases, are currently a vulnerable population, who report several health-related quality of life difficulties in their daily life. The emerging evidence also suggests the use of internet-based interventions may be an appropriate resource to support informal caregivers, particularly those finding it difficult to leave their home or demanding flexibility due to caregiving-related responsibilities. Moreover, the long distances to regular services of provision with the opportunity to do physical exercise or to attend conventional facilities, such as a gym, when the caregiver lives in small and/or rural municipalities, do not help either caregiver get involved in regular physical exercises programs. The aim of this study is to evaluate the cost-effectiveness and the effects of a tailored internet-based physical exercise intervention for female family caregivers on their health-related quality of life. Several dimensions of health (physical and mental) will be evaluated: health-related fitness variables (balance, body composition, muscular strength, endurance, and flexibility); subjective burden, anxiety, depression, psychological symptoms and global health-related quality of life. The cost-utility of the intervention will be also evaluated.

Who can participate?
Female caregivers aged 40 or older living at home with a relative with dementia

What does the study involve?
Participants are randomly divided into two groups: the intervention/exercise group and the control group. The intervention program will be carried out by a Graduate in Sport Sciences personal trainer by videoconference. The exercise group will perform 3-weekly sessions of physical exercise with a duration of 60 minutes for 9 months. The control group will not receive any treatment during the 9 months of the intervention. Participants are assessed at the start of the study, 3 months after the intervention and at 12 months (follow-up).

What are the possible benefits and risks of participating?
Although it has been previously well documented that interventions that are based on physical exercises are beneficial for health (physical and psychological, as this exercise program is provided at caregivers’ homes and is also adapted to the caregivers’ needs (less time-consuming, they do not need to look for another caregiver while performing the session). However, the following potential adverse effects of the intervention have to be taken into account. First, physical harm or injuries. In this case, if the participant is severely injured, the personal trainer will recommend the caregiver to visit the doctor. If the caregiver is not able to continue the intervention because of the injury, she should withdraw the intervention. Second, caregivers may feel resentful while carrying out physical exercises. Finally, the session of physical exercise might be interrupted because of caregivers’ behaviours.

Where is the study run from?
University of Extremadura (Spain)

When is the study starting and how long is it expected to run for?
January 2011 to December 2012

Who is funding the study?
Institute for the Elderly and Social Services, Ministry of Health and Social Policy (Spain)

Who is the main contact?
Prof. Narcís Gusi Fuertes
ngusi@unex.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Narcis Gusi Fuertes

ORCID ID

http://orcid.org/0000-0002-1001-8883

Contact details

Faculty of Sport Sciences
University of Extremadura
Av. de la Universidad S/N
Caceres
10073
Spain
+34 (0)927257460
ngusi@unex.es

Type

Scientific

Additional contact

Mr Miguel Madruga Vicente

ORCID ID

http://orcid.org/0000-0001-6410-0519

Contact details

Faculty of Sport Sciences
University of Extremadura
Av. de la Universidad S/N
Cáceres
10073
Spain
+34 (0)927257460
miguelmadruga@unex.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

185/2010

Study information

Scientific title

Cost-effectiveness of an interactive home-based tele-exercise program for informal caregivers of patients with dementia in a rural environment: gender perspective

Acronym

Study hypothesis

An interactive physical exercise program for informal caregivers of patients with dementia in rural settings is 1) applicable, 2) effective at improving health-related quality of life and fitness, and 3) a cost-effective resource to complement the usual healthcare system

Ethics approval

Approved 26/01/2010, Biomedical Ethics Commission of the University of Extremadura (Comité de Bioética y Bioseguridad. Vicerrectorado de Investigación, Transferencia e Innovación, Edificio Rectorado, Av. Elvas, S/N, 06006 – Badajoz, Spain; +34 (0)924289305 Ext: 9305; vrinvestigacion@unex.es), ref: 7/2010

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Informal caregivers of people with dementia (Alzheimer's disease or vascular)

Intervention

A controlled longitudinal experimental design will be applied with randomisation in the home environment of the main caregivers of patients with dementia for 12 months. The intervention period will be 9 months but the effects will also be evaluated at 12 months (3 months post-treatment). The sample will be randomly divided into two groups: intervention or exercise group and the control group.

The intervention program will be carried out by a Graduate in Sport Sciences personal trainer by videoconference. The exercise group will perform 3-weekly sessions of physical exercise with a duration of 60 minutes for 9 months.

The control group will not receive any treatment during the 9 months of the intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at baseline, at 3 months after the intervention and at 12 months (follow-up for cost-utility analysis):
1. Sociodemography and habits (physical activity, nutrition) measured using sociodemographic questionnaire, International Physical Activity Questionnaire and Mini-Nutritional Assessment
2. Cost-utility, use of the health system, and health-related quality of life measured using EQ-5D and SF-36 questionnaires
3. Caregiver burden measured using Zarit Burden Interview
4. Back pain measured using Rolando Morris questionnaire
5. Health-related fitness measured using functional fitness tests: Body Mass Index, Tinneti Balance, Time Up and Go, Functional Reach, Bi-handgrip strength, Curl-Up and Ito-Shirado Test, Stretching of the trunk, flexibility ROM Test, cardiovascular endurance by Canadian Step Test and balance by Biodex Balance Platform
6. Psychological symptoms measured using Global Depression Scale and Symptom Check-List 90 Revised
7. Adherence to the program measured using register of sessions
8. Health status of the patient with dementia measured using Global Deterioration Scale of Reisgberg, Barthel Index and EQ-5D-3L proxy

Secondary outcome measures

1. Adherence to physical exercise program measured using register of the number of sessions performed at 3 months after the intervention.
2. Health status of patients measured using the Global Deterioration Scale, Barthel Index and EQ-5D-3L at baseline, at 3 months after the intervention and at 12 months (follow-up for cost-utility analysis)

Overall trial start date

30/01/2011

Overall trial end date

20/12/2012

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Female
2. Provision of at least 20 h of unpaid per week, in-person care per week to a relative living at home with dementia
age ≥40 years
3. No medical condition that would limit participation in moderate-intensity exercise program
4. No participation in any regular physical activity program (i.e., has engaged in less than two >20-min sessions of exercise per week during the previous 36 months)
5. No changes in medication for at least 6 months prior to study entry; and no plans to move from the place of residence within 12 months of study entry

Participant type

Carer

Age group

Adult

Gender

Female

Target number of participants

52 (26 in the control group and 26 in the exercise group)

Total final enrolment

40

Participant exclusion criteria

1. Caregiver aged below 40 years
2. Caregivers participating in another physical exercise-based intervention
3. Medical contraindication to practise physical exercise

Recruitment start date

01/05/2011

Recruitment end date

30/07/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Federation of Associations of Family Caregivers of patients with Alzheimer Disease and other dementias in Extremadura
Avda. del Pilar, 74
Don Benito (Badajoz)
06400
Sudan

Sponsor information

Organisation

Institute for the Elderly and Social Services (Instituto de Mayores y Servicios Sociales)

Sponsor details

Ministerio de Sanidad y Política Social
Calle Ginzo de Limia Nº58 c/v s/n
Av. de la Ilustración
Madrid
28029
Spain
+34 (0)901 10 98 99
buzon@imserso.es

Sponsor type

Government

Website

https://www.imserso.es/imserso_01/index.htm

Funders

Funder type

Government

Funder name

Institute for the Elderly and Social Services (Instituto de Mayores y Servicios Sociales)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A study protocol will be published in a peer-reviewed journal after the ISRCTN is provided. Planned publication of the study results in a high-impact peer-reviewed journal within the next 3 months.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

11/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/05/2020: Trial's existence confirmed by Ministry of Health and Social Policy (Spain).