AzTrials
AzTrials

HealthyPRHCARERNCT06832709

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

A study testing a program of rehabilitation in people with Healthy, run by Lille University at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
a program of rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteFrance
Study dates
15 Mar 2025to 30 Nov 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claudine Fabre contact

+33 3 74 00 82 00

claudine.fabre@univ-lille.fr

France1 site, 1 recruiting

  • Participant'S Home

    Lille

    Claudine Fabre, PhD, +33 3 74 00 82 00, claudine.fabre@univ-lille.fr

    Recruiting

Other trials in France

About this study

Official title: Etat Des Lieux de la santé Physique, Sociale et Psychologique Des Aidants Dans le Cadre Des Maladies Respiratoires Chroniques

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.

Read the detailed description

The literature reports more anxiety and depressive symptoms , a greater psychological and social burden and a poorer quality of life in caregivers than in their non-caregivers peers. Knowing the fitness of caregivers, by means of an assessment of their abilities, would make it possible to define their profile, which should reflect an altered fitness linked to a state of ill-being. The results of these assessments would make it possible to establish a prevention policy, and following a rehabilitation programme for their patients, their health should improve. For caregivers who agree to take part in the study, their physical, mental and social health will be assessed. The total duration of the visit, including all the assessments, is estimated at 1h30. We expect the fitness and mental and social state of all the caregivers to deteriorate in line with the indicators available in the literature for people of the same age who are not carers. Following care of the patients, we expect an improvement in fitness and mental state of the carers.

Conditions
Healthy
Being tested
a program of rehabilitation
Keywords
caregivers, fitness, mental health, chronic respiratory disease
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a program of rehabilitationOther

    physical activities, health education, psychosocial and motivational support

Study groups in NCT06832709
Study groupRoleWhat they receive
program of rehabilitation at homeExperimentalgroup of caregivers which their loved ones followed a program of rehabilitataion at home
a program of rehabilitation in a specialized centerActive comparatorgroup of caregivers which their loved ones followed a program of rehabilitation in a specialized center
Receives: Other: a program of rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. functional capacity

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

    Measured: 8 weeks

Secondary outcomes (9)

  1. assessments of fitness

    handgrip

    Measured: 8 weeks

  2. Short battery physical fitness test

    SPPB (Short Physical Performance Battery) is the sum of the scores following 3 criteria: the balance test, the walking speed test and the chair rise test. This test makes it possible to evaluate an individual's physical performance.

    Score: 0 to 12 with best performance at 12.

    Measured: 8 weeks

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

    Test of: 5 questions offering a score between 1 and 5. Final score: 5 the best result, 15 the worst result.

    Helps to indicate how good or bad a state of health is, with a graduated scale (like that of a thermometer) on which 100 is the best state of health you can imagine and 0 is the worst state of health you can imagine. you can imagine.

    This scale is numbered from 0 to 100:

    • 100 is the healthiest imaginable.
    • 0 is the worst health imaginable.

    Measured: 8 weeks

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

    10 questions regarding the usual state. With 5 answer options ranging from "never (1)" to "always (5)" The total score is between 10 and 50. (10 = less fatigue, 50 = significant fatigue)

    Measured: 8 weeks

  5. Charlson Comorbidity Score

    Evaluates the level of comorbidity by considering the severity level of 19 predefined comorbidity disorders The investigator counts the number of points without indicating the items. Score 0 to 39 pts. 0 being the least and 39 being the serious

    Measured: 8 weeks

  6. Visual analog scales to measure shortness of breath and fatigue felt in the legs

    Two score scales ranging from 0 to 10 assessing the intensity of fatigue, shortness of breath and fatigue in the legs. 0 being the least serious and 10 being the highest fatigue.

    Measured: 8 weeks

  7. Questionnaire on the Perceived Social Burden of Caregivers (Zarit et al., 1986)

    22 questions on the different feelings of caregivers regarding their personal situations in the context of patient care.

    Answers ranging from never (0) to almost always (4) Total score ranging from 0 to 88 pts 0 being the most serious month and 88 being the most serious.

    Measured: 8 weeks

  8. Anxiety and Depression Symptoms Questionnaire (Zigmond et al. 1983)

    To detect anxious and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D):

    Total score in 2 categories (A = anxiety and D = depression) 0 = least serious score 21 = worst score

    Measured: 8 weeks

  9. EPICES social insecurity questionnaire (Sass et al. 2006)

    questions on the means, assistance, leisure and housing of the caregiver. The score is continuous, it varies from 0 (absence of precariousness) to 100 (maximum of precariousness). The threshold of 30 is considered the precariousness threshold according to EPICES.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start15 Mar 2025
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel assignment (2 groups)
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06832709
Sponsor's protocol ID
D2024-6
Acronym
PRHCARER
Status last verified
Sep 2026
First submitted
27 Jan 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30661022

  • 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.

    PubMed 15540670

  • 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.

    PubMed 36655219

  • Robic M, Grosbois JM, Racodon M, Le Rouzic O, Ramon P, Masson N, Fabre C, Gephine S. PRHOCARER study: protocol for a multicentre, convergent, mixed-methods trial assessing the effectiveness of pulmonary rehabilitation programmes and the needs of informal carers of people with chronic respiratory diseases. BMJ Open Respir Res. 2026 Mar 4;13(1):e003599. doi: 10.1136/bmjresp-2025-003599.

    PubMed 41781169

Questions about this trial

What is this clinical trial studying?

A study testing a program of rehabilitation in people with Healthy, run by Lille University at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudine Fabre (+33 3 74 00 82 00, claudine.fabre@univ-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

functional capacity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06832709, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in