NCT02044939

Brief Summary

The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program. The secondary objectives are the following:

  • assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
  • assess the improvement of exercise capacity by tests used in medical practice
  • assess the correlation between daily activity and exercise capacity
  • assess the improvement of dyspnea
  • assess the improvement of quality of life and psychological state

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

5.9 years

First QC Date

January 22, 2014

Last Update Submit

June 19, 2018

Conditions

Stage 4 Pulmonary Sarcoidosis

Keywords

Sarcoidosis, pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET)

    In everyday life, it corresponds to a walking in 5 km/h or in domestic chores. This measure will be realized by using Armband's accelerometer, in ambulatory. The measure will be realized over a period of 4 full days including the weekend.

    12 months

Secondary Outcomes (8)

  • Daily activity assessed by time spent in moderate activity (superior to 2,5 MET)

    2 and 6 months

  • exercise capacity assessed by symptom-limited cardiopulmonary exercise test, 6 minutes walk test, endurance test on bicycle, St Etienne questionnaire, 6 minutes stepper test

    2, 6 and 12 months

  • MRC scale for dyspnea

    2, 6 and 12 months

  • Questionnaire to evaluate quality of life and/or psychological state : VSRQ

    2, 6 and 12 months

  • Questionnaire to evaluate quality of life and/or psychological state : MRF 28

    2, 6 and 12 months

  • +3 more secondary outcomes

Study Arms (2)

Pulmonary rehabilitation

EXPERIMENTAL

Sarcoidosis patients will realize a pulmonary rehabilitation program

Other: Pulmonary rehabilitation program

Controls

NO INTERVENTION

Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling.

Interventions

Pulmonary rehabilitation programOTHER

Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)

Pulmonary rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage IV Sarcoidosis
  • Dyspnea on exertion
  • Age over 18 years

You may not qualify if:

  • Physical disability does not allow the creation of a rehabilitation program
  • Inability to give written consent to the study
  • Refusal of contraception in women of childbearing age
  • Inability to participate in the entire study
  • No cover by the social security system
  • Inability to perform self-questionnaires etude
  • The trial does not include special populations include:
  • Pregnant women
  • Breastfeeding women
  • People in emergencies
  • Persons unable to consent
  • Persons deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Clinique des Maladies Respiratoires, CHRU de LILLE

Lille, Nord, 59037, France

Location

Service de Pneumologie, CH Béthune

Béthune, Pas De Calais, 62408, France

Location

Service de Pneumologie, CH Arras

Arras, 62000, France

Location

Service de pneumologie, Hôpital Avicenne AP-HP

Bobigny, 93009, France

Location

CHU Nord, APHM Marseille

Marseille, 13354, France

Location

Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice

Nice, 06002, France

Location

Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP

Paris, 75015, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Hôpital Maison Blanche, CHU de Reims

Reims, 51100, France

Location

Service de Pneumologie, Hôpital Victor Provo

Roubaix, 59056, France

Location

Clinique des Voies Respiratoires, Hôpital Larrey

Toulouse, 31059, France

Location

Related Publications (1)

  • Wallaert B, Kyheng M, Labreuche J, Stelianides S, Wemeau L, Grosbois JM. Long-term effects of pulmonary rehabilitation on daily life physical activity of patients with stage IV sarcoidosis: A randomized controlled trial. Respir Med Res. 2020 Mar;77:1-7. doi: 10.1016/j.resmer.2019.10.003. Epub 2019 Oct 28.

    PMID: 31855785DERIVED

MeSH Terms

Conditions

Sarcoidosis, PulmonarySarcoidosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Benoît WALLAERT, MD PhD

    Clinique des Maladies Respiratoires, CHRU de Lille

    PRINCIPAL INVESTIGATOR

  • Frédéric BART, MD

    Service de Pneumologie, CH Béthune

    PRINCIPAL INVESTIGATOR

  • Dominique VALEYRE, MD PhD

    Service de pneumologie, Hôpital Avicenne AP-HP

    PRINCIPAL INVESTIGATOR

  • Dominique ISRAEL-BIET, MD PhD

    Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP

    PRINCIPAL INVESTIGATOR

  • Jean AMOURETTE, MD

    Service de Pneumologie, CH Arras

    PRINCIPAL INVESTIGATOR

  • Yves PACHECO, MD PhD

    Centre Hospitalier Lyon Sud

    PRINCIPAL INVESTIGATOR

  • Vincent COTTIN, MD PhD

    Service de Pneumologie, Hôpital Louis Pradel, Lyon

    PRINCIPAL INVESTIGATOR

  • Martine REYNAUD-GAUBERT, MD PhD

    CHU Nord, APHM Marseille

    PRINCIPAL INVESTIGATOR

  • Sylvie LEROY, MD

    Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice

    PRINCIPAL INVESTIGATOR

  • Gaëtan DESLEE, MD

    Hôpital Maison Blanche, CHU de Reims

    PRINCIPAL INVESTIGATOR

  • François STEENHOUWER, MD

    Service de Pneumologie, Hôpital Victor Provo, Roubaix

    PRINCIPAL INVESTIGATOR

  • Alain DIDIER, MD

    Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

July 10, 2012

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)