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Trial record 2 of 5 for:    19180335 [PUBMED-IDS]

Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale

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ClinicalTrials.gov Identifier: NCT03251781
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina

Brief Summary:
Background: The ability to perform activities of daily living (ADL) in patients with chronic obstructive pulmonary disease is often impaired. Glittre-ADL Test has been used to assess limitations in ADL, and it seems to be responsive to intervention. However, the minimal detectable change for Glittre-ADL Test remains unknown. Design: Non-controlled before and after study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation program in Florianopolis, Brazil. Subjects: Patients with COPD (GOLD II-IV). Interventions: Pulmonary rehabilitation program based on physical training, conducted over 24 sessions supervised, three times a week, including aerobic training in treadmill and localized training for upper limbs and lower limbs. Main measures: Glittre ADL-Test performance, six-minute walk test performance, London Chest Activity of Daily Living score, Modified Medical Research Council score, COPD Assessment Test score, Saint George Respiratory Questionnaire score before and after the pulmonary rehabilitation program.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Other: Pulmonary Rehabilitation Not Applicable

Detailed Description:

Assigned Interventions: Pulmonary rehabilitation program (PRP) was conducted according to the guidelines of the American Thoracic Society/European Respiratory Society (ATS/ERS). Physical training was conducted over 24 sessions supervised, three times a week. The program included aerobic training in treadmill (with 30 min load determined by the dyspnea sensation - 4 to 6 on the modified Borg scale) and localized training for upper limbs with free weights or elastic bands (movements performed based on the proprioceptive neuromuscular facilitation diagonals, performed in two series, lasting two minutes each) and lower limbs (quadriceps and triceps sural) with free weights and/or in the bodybuilding station .

Pulmonary function test: Spirometry will be performed before the PRP, and it will be in accordance with ATS/ERS standards in order to provide the level of pulmonary obstruction and severity of disease. The predicted values will be calculated with the equations derived from Brazilian population.

Glittre-ADL Test: The patients will be instructed to complete five laps on the follow circuit as quickly as possible: from a sitting position, the subject stands up and walks along a flat 10-m long course, in the middle of which there is a two-step ladder (each step 17 cm high x 27 cm deep) to be climbed; after completing the 10 m, the subject faces a shelf containing three 1-kg objects positioned on the top shelf (shoulder height) and moves them one by one to the bottom shelf (waist height) and then to the floor; the objects are then returned to the bottom shelf and finally to the top shelf again; the subject walks back, climbing up and down the steps, until reaching the starting point (chair), sits down and immediately begins the next lap. The subjects carry a weighted backpack (2.5 kg for women, 5.0 kg for men). Two Glittre-ADL Tests will be conducted before and after the PRP.

Six minute walk test (6MWT): The patients will be instructed to walk in order to perform the largest distance during six minutes. The walking speed will be selected by the patient, according to the guidelines of the ATS. Two 6MWTs will be conducted before and after the PRP.

London Chest Activity of Daily Living scale: Patients will be asked about their perception of limitation in activities of daily living, using the London Chest Activity of Daily Living scale (LCADL) before and after the PRP.

Modified Medical Research Council scale: Patients will be asked about their perception of dyspnea, using the modified Medical Research Council scale before and after the PRP.

Saint George Respiratory Questionnaire: Patients will be asked about their perception of health-related quality of life, using the Saint George Respiratory Questionnaire before and after the PRP.

COPD Assessment Test (CAT): Patients will be asked about their perception of the impact of COPD (cough, sputum, dyspnea, and chest tightness) on health status, using CAT before and after the PRP.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale in Patients With COPD
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Rehabilitation

Arm Intervention/treatment
Experimental: Pulmonary Rehabilitation
Pulmonary Rehabilitation
Other: Pulmonary Rehabilitation
Pulmonary rehabilitation program (PRP) was conducted according to the guidelines of the American Thoracic Society/European Respiratory Society (Nici et al., 2006; Spruit et al., 2013). Physical training was conducted over 24 sessions supervised, three times a week. The program included aerobic training in treadmill (with 30 min load determined by the dyspnea sensation - 4 to 6 on the modified Borg scale) and localized training for upper limbs with free weights or elastic bands (movements performed based on the proprioceptive neuromuscular facilitation diagonals, performed in two series, lasting two minutes each) and lower limbs (quadriceps and triceps sural) with free weights and/or in the bodybuilding station.




Primary Outcome Measures :
  1. Glittre ADL-Test [ Time Frame: The change in the Glittre ADL-test performance from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation). ]
    Change in Glittre ADL-Test performance

  2. London Chest Activity of Daily Living [ Time Frame: The change in the London Chest Activity of Daily Living score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation). ]
    Change in London Chest Activity of Daily Living score


Secondary Outcome Measures :
  1. Six-minute walking test [ Time Frame: The change in the distance walked during the six-minute walking test from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation). ]
    Change in six-minute walking test performance

  2. Modified Medical Research Council [ Time Frame: The change in the Modified Medical Research Council score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation). ]
    Change in Modified Medical Research Council score

  3. COPD Assessment Test (CAT) [ Time Frame: The change in the COPD Assessment Test (CAT) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation). ]
    Change in COPD Assessment Test (CAT) score

  4. Saint George Respiratory Questionnaire (SGRQ) [ Time Frame: The change in the Saint George Respiratory Questionnaire (SGRQ) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation). ]
    Change in Saint George Respiratory Questionnaire (SGRQ) score



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages II, III and IV)
  • Absence of change in respiratory symptoms in the past four weeks
  • No hospital admission in the past 12 weeks
  • Age between 40 and 80 years old

Exclusion Criteria:

  • Any other disease or health condition that could compromise the test´s execution or physical training
  • Participation in pulmonary rehabilitation program completed in the last six months
  • Interruption of pulmonary rehabilitation program for any reason
  • Current smoking or its cessation in less than six months
  • Any change in symptoms during the study protocol assessments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251781


Locations
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Brazil
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
University of the State of Santa Catarina
Florianópolis, Santa Catarina, Brazil, 88080-350
Sponsors and Collaborators
University of the State of Santa Catarina
Federal University of Health Science of Porto Alegre
Investigators
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Principal Investigator: Anamaria F Mayer, PhD University of the State of Santa Catarina

Publications:
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Mölken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dra. Anamaria Fleig Mayer, Principal Investigator, University of the State of Santa Catarina
ClinicalTrials.gov Identifier: NCT03251781     History of Changes
Other Study ID Numbers: 222/2011
063053/2014 ( Other Identifier: Universidade Federal de Ciências da Saúde de Porto Alegre )
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina:
Minimal Clinically Important Difference
Exercise Test
Rehabilitation
Disability Evaluation
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive