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Alberta Cancer Exercise Pilot Randomized Trial (ACE)

11 oktober 2018 uppdaterad av: Margie McNeely, University of Alberta

Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial

The purpose of the study is to examine the benefit and specific outcomes of a community-based exercise program that is designed to address the needs of individuals who are receiving or recovering from cancer treatment.

Eighty cancer survivors from Edmonton and Calgary will take part in the 24-week long study. Survivors will be randomly assigned to one of two groups. The first group will take part in an 8-week supervised exercise program followed by 8 weeks of self-directed or home-based exercise (early exercise group). The other 40 participants will continue with their normal activities for 16 weeks (delayed exercise group). After the 16 week period, participants in the delayed exercise group will take part in the 8-week supervised exercise program.

Exercise sessions will take place at selected YMCAs in Edmonton and Calgary. Exercise sessions will be supervised by specially trained exercise specialists who have received special training in exercise and cancer.

Outcomes of the study will include feasibility, physical fitness measures, cancer-related symptoms and quality of life.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Purpose: The primary purpose of this proposed study is to pilot test the planned Alberta Cancer Exercise (ACE) program evaluation components at the level of the individual cancer survivor. These components include program reach as well as effectiveness as determined by outcomes of physical fitness, symptoms, and quality of life. This proposed study will enable us to formalize an evaluation strategy to inform effectiveness and implementation of the ACE program.

Methods: A randomized controlled trial (RCT) design will be utilized to examine the short-term effectiveness of the proposed community-based cancer exercise program designed for cancer survivors. The study will take place at the Cross Cancer Institute/University of Alberta and Tom Baker Cancer Centre/ University of Calgary as well as in selected YMCA community fitness centres in Edmonton and Calgary. The exercise intervention will be delivered by specially trained exercise professionals who have completed the formal cancer exercise education course. Eighty participants will be randomized to early (intervention group) or delayed community-based exercise programming (standard care group). Participants randomized to the intervention group will undertake the ACE Program at a selected Edmonton and Calgary YMCA for an 8-week period. Following the 8-week supervised intervention period, participants will have the option to continue on a 'fee for service' basis or to continue with self-directed exercise at home. Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period. The standard care group will be offered participation in the 8-week ACE program at the completion of the 16-week follow-up period.

Outcomes: The primary outcome is program feasibility: recruitment, completion and adherence rates. For the purposes of the proposed study and the length of follow-up of 24 weeks, the RE-AIM components of Reach, Effectiveness and Implementation at the level of the individual will be evaluated as potential outcome indicators for the ACE program. Outcomes will include measures of health-related physical fitness, cancer-related symptoms and quality of life.

Summary: ACE is an active living initiative, encouraging cancer survivors in Alberta to take a role in their own wellbeing by supporting participation in cancer-specific community-based exercise programs.

Studietyp

Interventionell

Inskrivning (Faktisk)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 1N4
        • University of Calgary/ Tom Baker Cancer Centre
      • Edmonton, Alberta, Kanada, T6J4P9
        • University of Alberta/ Cross Cancer Institute

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Within 18 months of a diagnosis of any type of cancer
  2. Receiving or have received curative cancer treatment (e.g., surgery, chemotherapy, radiation therapy)
  3. Cleared for unrestricted physical activity by their treating oncologist

Exclusion Criteria:

  1. Presence of metastatic disease
  2. Any uncontrolled or serious comorbid conditions that would preclude participation in exercise testing and training
  3. Women who are pregnant

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Standard Care
Participants in this group will receive standard education on the importance of physical activity in the recovery from cancer and how to become more active. Participants assigned to this group will have the option to participate in the exercise program after the 16-week follow-up assessment.
Beteende: Education
Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.
Experimentell: Supervised Community-based Exercise
Participants in this group will take part in an 8-week supervised exercise program at the YMCA. Following the 8-week intervention, participants will have the option to continue for an additional 8-weeks at the YMCA (fee for service) or follow an 8-week self-directed program.
Beteende: Education
Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.
Beteende: Exercise
The participant exercise sessions will be conducted in small groups of 5 to 10 participants under the direct supervision of the community-based exercise specialist. Participants will have the choice between taking part in a bridging exercise class (e.g., Beauty program and Bridging to Fitness - Cancer) or group-based supervised fitness centre exercise training.
Andra namn:
  • Fysisk aktivitet

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility: number of participants completing the objective outcome measurements for the study
Tidsram: 24 weeks
Proportion of subjects completing the physical fitness tests including aerobic capacity, musculoskeletal fitness and body composition measurements.
24 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Aerobic Capacity
Tidsram: 8 weeks
Change in submaximal aerobic exercise capacity (treadmill, bike or 6 minute walk test)
8 weeks
Health-related Quality of Life
Tidsram: 8 weeks
Change in quality of life: Functional Assessment of Cancer Therapy General Questionnaire
8 weeks
Symptom Assessment
Tidsram: 8 weeks
Change in symptoms: Memorial Symptom Assessment Scale
8 weeks
Adherence to exercise
Tidsram: 24 weeks
Attendance at supervised exercise sessions
24 weeks
Recruitment rate
Tidsram: 18 months
Number of participants consenting to the study divided by the number of eligible participants
18 months
Upper Extremity Muscular Strength (optional)
Tidsram: 8 weeks
Change in 8 repetition maximum strength of chest press
8 weeks
Upper Extremity Grip Strength (optional)
Tidsram: 8 weeks
Hand Grip strength
8 weeks
Lower Extremity Muscular Strength (optional)
Tidsram: 8 weeks
Change in 8 repetition maximum strength of leg press
8 weeks

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adverse Events rate
Tidsram: 24 weeks
Number of serious and minor adverse events
24 weeks
Program Costs
Tidsram: 24 months
Costs related to study personnel, fitness centre costs and participant related costs
24 months
Body composition
Tidsram: 8 weeks
Body mass index
8 weeks

Samarbetspartners och utredare

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

Sponsor

University of Alberta

Samarbetspartners

AHS Cancer Control Alberta
University of Calgary

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 (Faktisk)

1 april 2015

Primärt slutförande (Faktisk)

1 december 2016

Avslutad studie (Faktisk)

30 juni 2018

Studieregistreringsdatum

Först inskickad

30 december 2014

Först inskickad som uppfyllde QC-kriterierna

2 januari 2015

Första postat (Uppskatta)

5 januari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 oktober 2018

Senast verifierad

1 april 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • HREBA-CC-14-0153

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

No plan in place

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