Physical Exercise Program for Family Caregivers of Dependent Patients

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status: Completed

Conditions: Physical Activity; Caregiver

Treatments: Other: PE; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03675217

GRS/VAE5-15

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

PE and PCFPC

Experimental group

Description:

Physical Exercise and primary care family caregivers program

Treatment:

Other: PE

Other: Usual Care

Usual Care

Active Comparator group

Description:

Usual Care: PCFPC (primary care family caregivers program)

Treatment:

Other: Usual Care