- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02757157
Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)
Determining the Metabolic Load of Walking in Water Compared to Walking on Land in People With COPD, Who Are Normal Weight and Obese, Compared to Peak Exercise Metabolic Response: a Prospective, Randomised Cross-over Pilot Trial
The purpose of this study is to evaluate the metabolic load during a single session of moderate intensity walking in water compared to walking on land (over-ground) in people with chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with peak exercise metabolic response.
The hypothesis is that the metabolic load of walking at a moderate intensity in water will be greater than walking on land.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Horn, Niederlande
- Centre of intergrated rehabilitation for chronic organ failure
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- diagnosis of COPD (FEV1/FVC <0.7) in a clinically stable state (no acute exacerbation of COPD within the previous 4 weeks)
- accepting of walking in water
- BMI >/= 21 kg/m2
Exclusion Criteria:
- long-term oxygen therapy
- contraindications to entering a hydrotherapy pool
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: COPD (normal weight)
People with COPD (BMI 21 kg/m2 to 29 kg/m2)
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Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. |
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Experimental: COPD (obese)
People with COPD (BMI >/= 30 kg/m2)
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Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Breath-by-breath oxygen consumption (VO2)
Zeitfenster: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Minute ventilation (VE)
Zeitfenster: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Dyspnoea, measured by the modified Borg 0-10 category ratio scale
Zeitfenster: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
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Exertion, measured by the modified Borg 0-10 category ratio scale
Zeitfenster: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
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Oxygen saturation
Zeitfenster: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
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Heart rate
Zeitfenster: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Martijn A Spruit, PhD, Centre of integrated rehabilitation for chronic organ failure
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ERS STRTF 2015 - 9368
Plan für individuelle Teilnehmerdaten (IPD)
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