Physical Exercise Program for Family Caregivers of Dependent Patients

NCT ID: NCT03675217

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-14
• Study Completion Date: 2016-06-20

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.

Conditions

Caregiver; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PE and PCFPC

Physical Exercise and primary care family caregivers program

Group Type: EXPERIMENTAL

PE

Intervention Type: OTHER

Physical exercise program for familiy caregivers. 36 session physical exercise (3 sessions/week) performed by physioterapist. It incluided exercices to improve coordination, aerobic capacity, control motor and strenght

Usual Care

Intervention Type: OTHER

Usual Programe in primary care for family caregivers. 4 session (2 session/week). It incluides: ergonomy, postural hygiene, mobilitation of patients and self-care.

Usual Care

Usual Care: PCFPC (primary care family caregivers program)

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual Programe in primary care for family caregivers. 4 session (2 session/week). It incluides: ergonomy, postural hygiene, mobilitation of patients and self-care.

Interventions

PE

Physical exercise program for familiy caregivers. 36 session physical exercise (3 sessions/week) performed by physioterapist. It incluided exercices to improve coordination, aerobic capacity, control motor and strenght

Intervention Type: OTHER

Usual Care

Usual Programe in primary care for family caregivers. 4 session (2 session/week). It incluides: ergonomy, postural hygiene, mobilitation of patients and self-care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Castilla-León Health Service

OTHER

Sponsor Role: collaborator

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Federico Montero Cuadrado

Role: PRINCIPAL_INVESTIGATOR

Castilla-Leon Health Service

Locations

Gerencia de Atención Primaria Valladolid-Este

Valladolid, Valladlid, Spain

Countries

Spain

Other Identifiers

GRS/VAE5-15

Identifier Type: -

Identifier Source: org_study_id