Informal caregivers of people with dementia (Alzheimer's disease or vascular) Not Applicable
Conditions
Interventions
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
Sponsors
Institute for the Elderly and Social Services (Instituto de Mayores y Servicios Sociales)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Caregiver aged below 40 years 2. Caregivers participating in another physical exercise-based intervention 3. Medical contraindication to practise physical exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Spain
Outcome results
None listed