Physical Exercise Program for Family Caregivers of Dependent Patients

NCT03675217 | Completed

• 1 other identifier: GRS/VAE5-15
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in Health-related Quality of Life at different time point

  Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) V2. Spanish version. The SF-36 is a 36- item scale constructed to survey health status and quality of life. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary. Each scale is directly transformed into a 0-100 scale. Higher scores indicate better overall quality of life.

  Change from baseline to post-treatment (16 weeks from baseline).

Secondary Outcomes (12)

• Change in burden caregiver at different time points

  Change from baseline to post-treatment (16 weeks from baseline).

• Changes in anxiety at different time points

  Change from baseline to post-treatment (16 weeks from baseline).

• Changes in depression

  Change from baseline to post-treatment (16 weeks from baseline).

• Change in pain assesment at different simple points

  Change from baseline to post-treatment (16 weeks from baseline).

• Change in disability

  Change from baseline to post-treatment (16 weeks from baseline).

Study Arms (2)

PE and PCFPC

EXPERIMENTAL

Physical Exercise and primary care family caregivers program

Other: PE; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

Usual Care: PCFPC (primary care family caregivers program)

Other: Usual Care

Interventions

PE 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

PE and PCFPC

Usual Care 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.

PE and PCFPC; Usual Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Investigacion y Formacion en Ciencias de la Salud: lead
• Castilla-León Health Service: collaborator

Study Sites (1)

Gerencia de Atención Primaria Valladolid-Este

Valladolid, Valladlid, 47010, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Federico Montero Cuadrado

  Castilla-Leon Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients evaluator and Outcomes Assessor are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 18, 2018
• Study Start: September 14, 2015
• Primary Completion: June 20, 2016
• Study Completion: June 20, 2016
• Last Updated: September 18, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)