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The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer (MOVE)

21 april 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

28

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: Active lifestyle programme
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.
Andra namn:
  • MOVE
Inget ingripande: Standard Care
Received usual care. Was offered the intervention after the completion of the study.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Tidsram: 0, 3, 6 months
0, 3, 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Tidsram: 0, 3, 6 months
0, 3, 6 months
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Tidsram: 0, 3, 6 months
0, 3, 6 months
Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Tidsram: 0, 3, 6 months
0, 3, 6 months
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Tidsram: 0, 3, 6 months
0, 3, 6 months
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Tidsram: 0, 3, 6 months
0, 3, 6 months
Change in intention to exercise
Tidsram: 0, 3, 6 months
assessed with Intention to exercise scale
0, 3, 6 months
Change in barriers to exercise
Tidsram: 0, 3, 6 months
assessed with Barriers to Exercise scale
0, 3, 6 months
Change in physical fitness
Tidsram: 0, 3, and 6 months
assessed with the modified Bruce treadmill test
0, 3, and 6 months
Change in upper body strength-grip strength
Tidsram: 0, 3, 6 months
Assessed with grip dynanometer
0, 3, 6 months
Change in upper body strength-upper arm strength
Tidsram: 0, 3, 6 months
Assessed with biceps curl test
0, 3, 6 months
Change in lower body strength
Tidsram: 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
Tidsram: 0, 3, 6 months
0, 3, 6 months
Change in antropometric measures (waist circumference, hip circumference
Tidsram: 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)
Tidsram: 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
Tidsram: 0, 3, 6 months
0, 3, 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of East Anglia

Utredare

  • Huvudutredare: John M Saxton, PhD, Northumbria University, Newcastle, United Kingdom

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2013

Primärt slutförande (Faktisk)

1 september 2014

Avslutad studie (Faktisk)

1 september 2014

Studieregistreringsdatum

Först inskickad

21 april 2016

Först inskickad som uppfyllde QC-kriterierna

21 april 2016

Första postat (Uppskatta)

26 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

26 april 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 april 2016

Senast verifierad

1 april 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 13/EE/0060

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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