Fitness and Well-being of Caregivers in the Hauts-de-France Region

NCT06832709 | Not Yet Recruiting

• 1 other identifier: D2024-6
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

The ageing of the population is accompanied by an increase in the frequency of chronic illnesses, leading to a rise in the number of caregivers. These caregivers do not have the time to look after their own health, and they are very often in a deteriorated mental state with no knowledge of their level of fitness. A deterioration in their fitness can be a source of the development of diseases induced by a sedentary lifestyle. On the other hand, patients with chronic respiratory disease can benefit from respiratory rehabilitation (RR), which includes outpatient or home-based physical activity. The literature has demonstrated an improvement in the mental state of caregivers following a RR carried out by their loved ones without taking an interest in their fitness. The aim of the study will be to establish 1. a representation of the level of fitness and mental state of caregivers; 2. to assess the presence/absence of benefits on fitness and mental state of caregivers depending on the form of RR: home versus outpatient where the caregiver is not integrated in this last form.

Conditions

Healthy

Keywords

caregivers; fitness; mental health; chronic respiratory disease

Outcome Measures

Primary Outcomes (1)

• functional capacity

  achieve the highest number of steps on a stepper in 6 minutes

  8 weeks

Secondary Outcomes (9)

• assessments of fitness

  8 weeks

• Short battery physical fitness test

  8 weeks

• Assessment of the state of health felt by the two parts of the EuroQol Group questionnaire (1990),

  8 weeks

• Physical and mental fatigue questionnaire (Michielsen et al. 2003)

  8 weeks

• Charlson Comorbidity Score

  8 weeks

Study Arms (2)

program of rehabilitation at home

EXPERIMENTAL

group of caregivers which their loved ones followed a program of rehabilitataion at home

Other: a program of rehabilitation

a program of rehabilitation in a specialized center

ACTIVE COMPARATOR

group of caregivers which their loved ones followed a program of rehabilitation in a specialized center

Other: a program of rehabilitation

Interventions

a program of rehabilitation OTHER

physical activities, health education, psychosocial and motivational support

a program of rehabilitation in a specialized center; program of rehabilitation at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of legal age;
• Have a sick relative taking part in a RR program, either as an outpatient at the Clinique de la Mitterie or at home with FormAction Santé;
• Have the cognitive ability to understand the instructions for carrying out the physical tests and the questions for answering the questionnaires;
• Be able to read;
• Have no disability preventing them from carrying out the physical tests;
• Have given their written consent to take part in the research;
• Be willing to comply with all the research procedures and duration.

You may not qualify if:

• Refusal to sign consent;
• Operation less than one month old;
• Presence of psychological or psychiatric disorders;
• Impossibility of receiving informed information;
• Impossibility of participating in the entire study;
• Contraindication to physical activity.

Sponsors & Collaborators

• Lille University: lead

Related Publications (3)

• Houben CHM, Spruit MA, Luyten H, Pennings HJ, van den Boogaart VEM, Creemers JPHM, Wesseling G, Wouters EFM, Janssen DJA. Cluster-randomised trial of a nurse-led advance care planning session in patients with COPD and their loved ones. Thorax. 2019 Apr;74(4):328-336. doi: 10.1136/thoraxjnl-2018-211943. Epub 2019 Jan 19.

  PMID: 30661022 BACKGROUND

• Seamark DA, Blake SD, Seamark CJ, Halpin DM. Living with severe chronic obstructive pulmonary disease (COPD): perceptions of patients and their carers. An interpretative phenomenological analysis. Palliat Med. 2004 Oct;18(7):619-25. doi: 10.1191/0269216304pm928oa.

  PMID: 15540670 BACKGROUND

• Grosbois JM, Gephine S, Kyheng M, Le Rouzic O, Chenivesse C. Improving the wellbeing of caregivers of patients with COPD using a home-based pulmonary rehabilitation programme. ERJ Open Res. 2022 Dec 12;8(4):00255-2022. doi: 10.1183/23120541.00255-2022. eCollection 2022 Oct.

  PMID: 36655219 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Claudine Fabre, PhD

  Lille University

  STUDY DIRECTOR

Central Study Contacts

Claudine Fabre

CONTACT

+33 3 74 00 82 00; claudine.fabre@univ-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment (2 groups)

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 18, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share