- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00864084
Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?
26. august 2014 opdateret af: Ms. Elizabeth Harvey, University of Manitoba
Does a Pulmonary Rehabilitation Program Improve Balance in Individuals With Respiratory Disease?
The purpose of this study is to determine whether participation in pulmonary rehabilitation improves balance in people with respiratory disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Falls and chronic respiratory are two major health concerns affecting morbidity and mortality in older adults.
Several factors that predispose falls, such as reduced balance, have been documented in people with respiratory disease.
Pulmonary rehabilitation programs, which involve customized exercise prescription, are recommended to improve quality of life and disease management in people with chronic obstructive pulmonary disease (COPD).
There are many documented benefits to participation in such programs; however, the impact on balance and other falls risk factors has not previously been investigated.
Therefore, the aim of this study is to investigate the effect of a pulmonary rehabilitation program on balance and falls risk factors in individuals with respiratory disease.
This study will enhance the current management of respiratory disease by improving our understanding of the effects of pulmonary rehabilitation.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0T6
- The University of Manitoba
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of lung disease
- Committed to regular attendance at pulmonary rehabilitation program
- A forced expiratory volume in 1 second (FEV1) < 80% of predicted
- No change in medications for the past 2 months
Exclusion Criteria:
- Unstable cardiac disease
- Neurological conditions
- Musculoskeletal conditions that prevent participation in exercise sessions.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Pulmonary rehabilitation
People with respiratory disease
|
Pulmonary rehabilitation involves the prescription of customized exercise programs and education on disease management.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Standing Balance - Sway Path
Tidsramme: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz.
Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.
|
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Dynamic Balance
Tidsramme: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Dynamic balance was measured using the timed up and go (TUG) and Four Square Step Test (FSST).
For the TUG, the time taken for the subject to stand from a chair, walk 3 m, turn around and return to the chair was recorded {Podsiadlo, 1991 #31}.
Subjects were asked to do this as quickly and safely as possible.
High test-retest reliability of the TUG has been reported in older community-dwelling individuals {Steffen, 2002 #34}.
In the FSST, subjects were asked to step to four corners of a square in a clockwise and then counter-clockwise direction as quickly as possible {Dite, 2002 #1181}.
The time taken to complete this circuit was recorded.
This test has been shown to have high inter-rater and test-retest reliability {Dite, 2002 #1181}.
|
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Standing Balance - Critical Point in Time
Tidsramme: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz.
Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.
|
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Standing Balance - Critical Point in Distance
Tidsramme: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz.
Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.
|
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Balance Confidence
Tidsramme: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Activity-Specific Balance Confidence (ABC) scale measures balance confidence during sixteen activities of progressive difficulty, such as going up and down stairs, reaching for objects and walking in crowded areas {Powell, 1995 #5}.
It asks subjects to rate their level of confidence in performing an activity without losing balance on an 11-point scale ranging from 0% (no confidence) to 100% (completely confident).
The score is calculated as the average score for each item.
This questionnaire has been shown to be sensitive to detect changes in function following rehabilitation {Myers, 1998 #6} and has proven internal consistency and test-retest reliability {Powell, 1995 #5}.
|
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Fear of Falling
Tidsramme: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
The Falls Efficacy Scale International (FESI) assesses fear of falling during a range of physical and social activities {Yardley, 2005 #1}.
It asks about an individual's concern about the possibility of following during participation in sixteen common activities, such as cleaning the house, ascending and descending stairs and walking in various environmental conditions.
Answers range from 1, "not at all" concerned, to 4, "very" concerned, on a 4-point scale, and score is calculated as the average response.
This questionnaire has been shown to have excellent internal and test-retest reliability {Yardley, 2005 #1}.
|
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Confidence in Disease Management
Tidsramme: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
The COPD Self-Efficacy Scale evaluates level of confidence in ability to manage or avoid breathing difficulty during a range of situations such as feeling frustrated and lifting heavy objects {Wigal, 1991 #3}.
Possible answers range from "very confident" (5 points) to "not at all confident" (1 point) and the average score per question is calculated.
This scale has been shown to have excellent internal consistency and good test-retest reliability.
|
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michelle D Smith, PhD, The University of Queensland
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2009
Primær færdiggørelse (Faktiske)
1. juni 2009
Studieafslutning (Faktiske)
1. december 2009
Datoer for studieregistrering
Først indsendt
17. marts 2009
Først indsendt, der opfyldte QC-kriterier
17. marts 2009
Først opslået (Skøn)
18. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B2009:007
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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