The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer (MOVE)
21. april 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Ikke anvendelig
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:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
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Ingen indgriben: Standard Care
Received usual care.
Was offered the intervention after the completion of the study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Tidsramme: 0, 3, 6 months
|
0, 3, 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Tidsramme: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Tidsramme: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Tidsramme: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Tidsramme: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Tidsramme: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in intention to exercise
Tidsramme: 0, 3, 6 months
|
assessed with Intention to exercise scale
|
0, 3, 6 months
|
|
Change in barriers to exercise
Tidsramme: 0, 3, 6 months
|
assessed with Barriers to Exercise scale
|
0, 3, 6 months
|
|
Change in physical fitness
Tidsramme: 0, 3, and 6 months
|
assessed with the modified Bruce treadmill test
|
0, 3, and 6 months
|
|
Change in upper body strength-grip strength
Tidsramme: 0, 3, 6 months
|
Assessed with grip dynanometer
|
0, 3, 6 months
|
|
Change in upper body strength-upper arm strength
Tidsramme: 0, 3, 6 months
|
Assessed with biceps curl test
|
0, 3, 6 months
|
|
Change in lower body strength
Tidsramme: 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
Tidsramme: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in antropometric measures (waist circumference, hip circumference
Tidsramme: 0, 3, 6 months
|
Waist and hip circumference will be used to calculate the waist-to-hip ratio
|
0, 3, 6 months
|
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Changes in anthropometric measures (height, weight, BMI)
Tidsramme: 0, 3, 6 months
|
Body weight and body height will be used to calculate BMI
|
0, 3, 6 months
|
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Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
Tidsramme: 0, 3, 6 months
|
0, 3, 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: John M Saxton, PhD, Northumbria University, Newcastle, United Kingdom
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. oktober 2013
Primær færdiggørelse (Faktiske)
1. september 2014
Studieafslutning (Faktiske)
1. september 2014
Datoer for studieregistrering
Først indsendt
21. april 2016
Først indsendt, der opfyldte QC-kriterier
21. april 2016
Først opslået (Skøn)
26. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13/EE/0060
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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