The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer (MOVE)
21. April 2016 aktualisiert von: University of East Anglia
Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer
Long-term maintenance of physical activity behaviour change post-intervention remains challenging.
This study is investigating the feasibility of a behaviour change intervention based on Self-Determination Theory in people recovering from colorectal cancer and its effects on behaviour change 6 months post-intervention.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study was a randomized controlled feasibility trial consisting of a 3-months active lifestyle intervention and a 3-months follow-up period. Participants were allocated to an active lifestyle programme (ALP) or the standard (SC) care group. ALP was offered 12 supervised exercise sessions over 3 months and six supportive behaviour change workshops. SC was encouraged to continue with their usual lifestyle. The intervention was informed by Self-Determination Theory.
The supervised exercise sessions took place in small groups of maximum 7 participants and lasted approximately 1 hour. Exercise included aerobic and resistance exercises. The behaviour change workshops were delivered in a motivational interviewing style, also in small groups of maximum 7 participants.
Participants were followed-up at 6 months. There was no contact with participants during the post-intervention and follow-up period.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
28
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- a histologically confirmed diagnosis of colorectal cancer with Dukes stages A-C
- completed cancer treatment within the last 24 months,
- be able to understand spoken and written English
- score of 80 or more on the Karnofsky Performance Status Scale
Exclusion Criteria:
- already meeting general PA guidelines of 150 min of moderate PA or 75 min of vigorous intensity PA per week,
- recent myocardial infarction
- uncontrolled hypertension
- a pacemaker
- or unstable angina.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Active Lifestyle Programme
Supervised exercises for 3 months and motivational interviewing to facilitate physical activity behaviour change.
Supervised exercise sessions took place twice per week for the first four weeks.
This was tapered off to once per week for the second four weeks.
During the last month of the intervention participants continued with the exercise at home and were encouraged to achieve 150min of moderate to vigorous PA per week.
|
The intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention.
Andere Namen:
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Kein Eingriff: Standard Care
Received usual care.
Was offered the intervention after the completion of the study.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Zeitfenster: 0, 3, 6 months
|
0, 3, 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Zeitfenster: 0, 3, 6 months
|
0, 3, 6 months
|
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Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Zeitfenster: 0, 3, 6 months
|
0, 3, 6 months
|
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Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Zeitfenster: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Zeitfenster: 0, 3, 6 months
|
0, 3, 6 months
|
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|
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Zeitfenster: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in intention to exercise
Zeitfenster: 0, 3, 6 months
|
assessed with Intention to exercise scale
|
0, 3, 6 months
|
|
Change in barriers to exercise
Zeitfenster: 0, 3, 6 months
|
assessed with Barriers to Exercise scale
|
0, 3, 6 months
|
|
Change in physical fitness
Zeitfenster: 0, 3, and 6 months
|
assessed with the modified Bruce treadmill test
|
0, 3, and 6 months
|
|
Change in upper body strength-grip strength
Zeitfenster: 0, 3, 6 months
|
Assessed with grip dynanometer
|
0, 3, 6 months
|
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Change in upper body strength-upper arm strength
Zeitfenster: 0, 3, 6 months
|
Assessed with biceps curl test
|
0, 3, 6 months
|
|
Change in lower body strength
Zeitfenster: 0, 3, 6 months
|
Assessed with 30 sec sit-to-stand test
|
0, 3, 6 months
|
|
Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
Zeitfenster: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in antropometric measures (waist circumference, hip circumference
Zeitfenster: 0, 3, 6 months
|
Waist and hip circumference will be used to calculate the waist-to-hip ratio
|
0, 3, 6 months
|
|
Changes in anthropometric measures (height, weight, BMI)
Zeitfenster: 0, 3, 6 months
|
Body weight and body height will be used to calculate BMI
|
0, 3, 6 months
|
|
Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
Zeitfenster: 0, 3, 6 months
|
0, 3, 6 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: John M Saxton, PhD, Northumbria University, Newcastle, United Kingdom
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2013
Primärer Abschluss (Tatsächlich)
1. September 2014
Studienabschluss (Tatsächlich)
1. September 2014
Studienanmeldedaten
Zuerst eingereicht
21. April 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. April 2016
Zuerst gepostet (Schätzen)
26. April 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
26. April 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. April 2016
Zuletzt verifiziert
1. April 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 13/EE/0060
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
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