Clinical trial NCT03675217: Physical Exercise Program for Family Caregivers of Dependent Patients
Official title: Physical Exercise Program for Family Caregivers of Dependent Patients: Randomized Clinical Trial in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Physical Activity
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
First posted: 2018-09-18
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This estudy evaluates the effects of physical exercise program on health related quality of life (HRQoL), pain and physical fitness in family caregiver.

Detailed description: Justification: Research indicates that the dependent patient caregiver´s have physical, psychological and social repercussions, as consequence of the care that they provide. From Primary Health Care there is a "caregiver care program" to prevent and palliate this situation, consisting mainly in education programs in care and psychotherapy. There is controversy about the effectiveness of these programs, being necessary to develop new therapeutic strategies.

Objectives: to determine the effects of a physical exercise program, adressed by the primary health care physioterapist, on health related quality of life (HRQol), pain and physical fitness in dependent patient caregivers included in the " caregiver care program" of a basic health area.

Methodology: randomized clinical trial, with control group (GC = 32) and intervention group (GI = 36), double blind and pre and post-intervention evaluation. The GC received the usual program of the " caregiver care program". The GI also carried out a multi-component exercise program for 12 weeks, with 3 weekly sessions realized in group and monitored by physiotherapists. The outcomes variables are measured by Quality of life (SF-36), Burden (Zarit), anxiety (Goldberg Ansiety Questionanaire), depression (Yesavage Questionnaire), pain intensity (EVA), disability (Roland Morris) and physical fitness (battery of fitness tests). Patients evaluator and Outcomes Assessor are masked.

Applicability of results: If the physical exercise program, carried out from the primary health care physiotherapy, improves the HRQol, pain and physical fitness, this intervention could be an effective therapeutic strategy in the "caregiver care programs". Furthermore the proposed intervention is simple, reproducible and requires few resources.

Eligibility criteria: Inclusion Criteria:

* Status as family caregiver and to be incluided in the "Caregiver care Program".
* Provided care to family dependent al least 6 months.
* Accept to participate in the study and sign the informed consent.
* No changes in medication for at least 3 months prior to study entry.

Exclusion Criteria:

* People whith associated pathologies that make it impossible to perform physical exercise program (moderate-intensity exercise).
* To be incluiding in other family care program
* Participation in any regular physical activity program.
* To have a formal caregiver to care for the dependent family member

Primary outcomes:
measure: Change in Health-related Quality of Life at different time point
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
Secondary outcomes:
measure: Change in burden caregiver at different time points
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Changes in anxiety at different time points
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Changes in depression
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Change in pain assesment at different simple points
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Change in disability
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Modifications of body mass index
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Changes in handgrip strength
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Changes in lower extremity function
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Changes in postural balance
timeFrame: Change from baseline to post-treatment (16 weeks from baseline)
measure: Changes in flexibility
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Changes in mobility
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
measure: Changes in maximal oxygen uptake (Vo2 max)
timeFrame: Change from baseline to post-treatment (16 weeks from baseline).
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Gerencia de Atención Primaria Valladolid-Este
state: Valladlid
Study officials:
affiliation: Castilla-Leon Health Service
name: Federico Montero Cuadrado
role: PRINCIPAL_INVESTIGATOR
References: