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Effects of Functional Exercise on Fitness and QoL in Cancer Survivors (RETRACE)

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Functional Resistance Training
Unsupervised activity
Sponsored by
University of Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female, aged 18-90
  • Been treated for colorectal cancer
  • Cancer stages I-IV
  • Cancer survivors will be eligible to participate if at least three months will have passed since their last treatment
  • Those who are within 5 years of their last cancer treatment
  • Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

  • Participants with previous FRT participation
  • Cancer survivors with cardiovascular insufficiency (i.e. recent myocardial infarction, acute myocarditis, and uncontrolled symptomatic heart failure)
  • Participants with cognitive or physical impairment leading to inability to exercise
  • Cancer survivors with severe anaemia (i.e. Haemoglobin < 8g/dl), symptoms of unusual fatigue, disorientation, faintness, pallor, blurred vision, ataxia, acute nausea and vomiting during the exercise session
  • Participants with immunosuppression (i.e. WBC < 500/mm3), absolute neutrophil count < 0.5×10 9μl and thrombocytopenia (Platelet count < 50× 109μl)

Sites / Locations

  • Andrew Scott

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Functional Resistance Training (FRT)

Arm Description

Unsupervised activity

Supervised, group-based functional resistance training

Outcomes

Primary Outcome Measures

Change in Global Health Status/QoL (subscale of EORTC QLQ-C30, Version 3) scores in cancer survivors
Change in QoL score

Secondary Outcome Measures

Change in EORTC QLQ-C30 (Overall)
Change in overall QoL score
Change in 6 minute walk distance
Improvement in metres walked
Change in Lift and carry test performance
Decrease in time taken to complete task
Change in Chair stand test performance
Improvement in seat to stand repetitions
Change in Handgrip strength score
Improvement in Newtons
Change in body mass
Decrease in body mass
Change in waist circumference
Decrease in cm
Change in body fat %
Decrease in body fat percentage
Change in Self-efficacy to regulate exercise scale score
Improvement in self-efifcacy

Full Information

First Posted
August 19, 2016
Last Updated
March 24, 2020
Sponsor
University of Portsmouth
Collaborators
Portsmouth Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02889276
Brief Title
Effects of Functional Exercise on Fitness and QoL in Cancer Survivors
Acronym
RETRACE
Official Title
Effects of a 12-week Functional Resistance Training Programme on Physical Fitness and Health-related Quality of Life in Colorectal Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Only 4 participants were recruited from 130 potential participants.
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Portsmouth
Collaborators
Portsmouth Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be the first to examine the effects of a functional resistance exercise programme that closely replicates daily activities and their effects on quality of life, body composition and functional fitness in cancer survivors. This study will also use a supervised and group based exercise setting to help with socialisation and confidence with an aim to improve the exercise experience. Eligible participants should be 18-90 years old, been treated for colorectal cancer (stages I-IV) in the previous 3 months to five years and with no limitations to exercise. The study will include a 12-week exercise period where participants will be randomly allocated to the control group or to take part in 32 supervised one-hour group exercise sessions involving exercises to target the whole body at a moderate intensity which will take place in the Mountbatten Centre, Pyramids Centre, Fareham Leisure Centre or Horizons Leisure Centres. Depending on participants' membership status those in the control group could use the centre's exercise referral programme, which has a cost attached, or they will be encouraged to meet national physical activity recommendations by walking 30 minutes per day on most days of the week. The only difference between the two groups will be the supervised group functional resistance training. At the beginning and end of the 12-week study period a number of health-related fitness tests will be performed to assess health outcomes, such as resting blood pressure & heart rate, respiratory function, body fat measures (body mass index, waist circumference and body fat %), functional performance measurements, handgrip strength, a 6 minute walk test and self-efficacy to regulate exercise and measures of quality of life questionnaires. Participants will be provided with their own results and an overview of the whole study data.
Detailed Description
Potential volunteers will be identified by the clinical care team and asked to contact the research team if they are interested in participating. The participants will be randomly allocated to either a control group or an exercise group and participate in the study. The control group will be asked to perform 150 minutes of moderate activity a week, such as 30 minutes of brisk walking on 5 days a week. The exercise group will be asked to participate in the FRT exercise sessions over 12-weeks. The exercise sessions will be performed with a frequency of 2 times a week (for weeks 1-4) and three times a week (for weeks 5-12). The exercise programme will include 10 muscle-strengthening exercises and 5 recovery exercises (for example walking for one minute). All the exercises will be performed in a circuit fashion and the circuit will be performed 1 time (for weeks 1-2), for 2 times (for weeks 3-6) and finally for 3 times during the last six weeks of the study (for weeks 7-12). During the main part of the workout participants will have to perform 10 repetitions at a moderate to vigorous intensity (for weeks 1-12) for each resistance exercise and they will alternate every two resistance exercises with one active recovery exercise (e.g. walking). They will continue this pattern until they complete the circuit. Each circuit will last approximately 15 minutes (1 minute for each of the 10 resistance exercise stations and 1 minute for each of the 5 active recovery stations) Both before and after their participation in the study, the researcher will take anthropometric (body weight, height, waist and hip circumference, body fat % and lean body mass) measurements and the participants will perform four physical fitness tests (6 minutes walking test, hand grip strength, lift and carry test, chair stand test) in order to assess the effects of exercise on their physical fitness and to answer the quality of life questionnaire. At least 12 hours before it is important for them to abstain from participating in any strenuous physical activity and alcohol/caffeine consumption. In addition, their last meal should be consumed 4 hours before testing. In addition, they will be given a physical activity diary and during the 12-week study period they will have to record their daily activity. Participants of the exercise group will also receive a weight-training diary, where they will record their progress in the FRT stations (i.e. the increase in resistance load for each FRT exercise).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Unsupervised activity
Arm Title
Functional Resistance Training (FRT)
Arm Type
Experimental
Arm Description
Supervised, group-based functional resistance training
Intervention Type
Other
Intervention Name(s)
Functional Resistance Training
Intervention Description
Supervised group-based Functional Resistance Training
Intervention Type
Behavioral
Intervention Name(s)
Unsupervised activity
Intervention Description
General activity to meet 150 minutes of moderate intensity activity per week
Primary Outcome Measure Information:
Title
Change in Global Health Status/QoL (subscale of EORTC QLQ-C30, Version 3) scores in cancer survivors
Description
Change in QoL score
Time Frame
Baseline and after the 12-week study period
Secondary Outcome Measure Information:
Title
Change in EORTC QLQ-C30 (Overall)
Description
Change in overall QoL score
Time Frame
Baseline and after the 12-week study period
Title
Change in 6 minute walk distance
Description
Improvement in metres walked
Time Frame
Baseline and after the 12-week study period
Title
Change in Lift and carry test performance
Description
Decrease in time taken to complete task
Time Frame
Baseline and after the 12-week study period
Title
Change in Chair stand test performance
Description
Improvement in seat to stand repetitions
Time Frame
Baseline and after the 12-week study period
Title
Change in Handgrip strength score
Description
Improvement in Newtons
Time Frame
Baseline and after the 12-week study period
Title
Change in body mass
Description
Decrease in body mass
Time Frame
Baseline and after the 12-week study period
Title
Change in waist circumference
Description
Decrease in cm
Time Frame
Baseline and after the 12-week study period
Title
Change in body fat %
Description
Decrease in body fat percentage
Time Frame
Baseline and after the 12-week study period
Title
Change in Self-efficacy to regulate exercise scale score
Description
Improvement in self-efifcacy
Time Frame
Baseline and after the 12-week study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female, aged 18-90 Been treated for colorectal cancer Cancer stages I-IV Cancer survivors will be eligible to participate if at least three months will have passed since their last treatment Those who are within 5 years of their last cancer treatment Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: Participants with previous FRT participation Cancer survivors with cardiovascular insufficiency (i.e. recent myocardial infarction, acute myocarditis, and uncontrolled symptomatic heart failure) Participants with cognitive or physical impairment leading to inability to exercise Cancer survivors with severe anaemia (i.e. Haemoglobin < 8g/dl), symptoms of unusual fatigue, disorientation, faintness, pallor, blurred vision, ataxia, acute nausea and vomiting during the exercise session Participants with immunosuppression (i.e. WBC < 500/mm3), absolute neutrophil count < 0.5×10 9μl and thrombocytopenia (Platelet count < 50× 109μl)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew T Scott, PhD
Organizational Affiliation
University of Portsmouth
Official's Role
Study Chair
Facility Information:
Facility Name
Andrew Scott
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO1 2ER
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared

Learn more about this trial

Effects of Functional Exercise on Fitness and QoL in Cancer Survivors

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