Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects

5. september 2019 opdateret af: Aslihan CAKMAK, Hacettepe University

The purpose of this study is to compare physical activity levels between patients with bronchiectasis and healthy subjects.

We hypothesize that patients with bronchiectasis will have lower levels of physical activity, since physical activity levels is affected by reduced exercise tolerance, severity of disease and other disease related symptoms and conditions.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Physical activity limitation in chronic respiratory diseases is caused by many factors including respiratory, hemodynamic, and peripheral muscle weakness. Bronchiectasis is characterized by irreversible widening of the medium-sized airways, with inflammation, chronic bacterial infection and destruction of the bronchial walls. In addition to pulmonary function worsening, extra pulmonary features such as reduced peripheral muscle endurance can be a significant physical problem which causing a decrease in physical activity levels.

Despite physical activity is considered to be essential for the management of chronic respiratory diseases, there is a lack of scientific study, which compares physical activity levels between patients with bronchiectasis and healthy subjects.

This study will assess physical activity level, exercise capacity, quality of life and peripheral muscle strength in patients with bronchiectasis compared to healthy subjects.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

76

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Ankara, Kalkun, 06100
        • Aslihan Cakmak

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The study population will consist of patients with bronchiectasis and healthy subjects.

Beskrivelse

Inclusion Criteria:

Inclusion criteria of the Bronchiectasis Group:

  1. Diagnosis of bronchiectasis
  2. Being 18 years of age or older
  3. Able and willing to complete the informed consent process.
  4. Able to walk and co-operate

Exclusion Criteria:

Exclusion criteria of Bronchiectasis Group:

  1. Unstable medical condition
  2. To have severe neurological, orthopedic problems or severe heart failure.

The control group will consist of healthy subjects.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of steps on accelerometer
Tidsramme: Seven days
Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
Seven days
Energy expenditure on activity monitor
Tidsramme: Seven days
Total energy expenditure will be calculated using activity monitor for seven consecutive days
Seven days
Exercise capacity using 6-minute walk test and incremental shuttle walk test
Tidsramme: 8th day (after using device)

6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded.

The incremental shuttle walk test will be performed in an enclosed corridor. Patients are required to walk back and forth, turning around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients will follow the rhythm dictated by the audio signal.

8th day (after using device)
Physical activity level using International Physical Activity Questionnaire
Tidsramme: 8th day
Instrument to obtain internationally comparable data on health related physical activity This measure assesses the types of intensity of physical activity and sitting time in daily life and estimates total physical activity in MET-min/week and time spent sitting. It comprises open-ended questions surrounding individuals' last 7-day recall of physical activity.
8th day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Shortness of breath using the Modified Medical Research Council Dyspnea Scale
Tidsramme: 1st day (before using device)
Scale is used to establish functional impairment due to dyspnea attributable to respiratory disease. The scoring ranges from 0 to 4. The higher scores indicate higher perception of dyspnea.
1st day (before using device)
Quality of Life using St. George Respiratory Questionnaire
Tidsramme: 1st day
It measures the health impairment. The questionnaire consist of 50 items, 2 parts (3 components). The name of categories/domains were stated as follows: Part 1: Symptoms component (frequency&severity), Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease). The scores range from 0 to 100, with higher scores indicating more limitations.
1st day
Peripheral muscle strength test using a hand-held dynamometer
Tidsramme: 8th day (after using device)
Measurement of peripheral muscle strength
8th day (after using device)
Maximal inspiratory and expiratory pressures measurement using a mouthpiece device
Tidsramme: 8th day (after using device)
Measurement of respiratory muscle strength
8th day (after using device)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: ASLIHAN CAKMAK, Hacettepe University

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 (Faktiske)

1. september 2015

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

13. september 2015

Først indsendt, der opfyldte QC-kriterier

14. september 2015

Først opslået (Skøn)

16. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GO 15/313

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 .

3
Abonner