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

Effects of a 12-week Functional Resistance Training Programme on Physical Fitness and Health-related Quality of Life in Colorectal Cancer Survivors

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Unsupervised activity; Other: Functional Resistance Training

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO1 2ER
      • Andrew Scott

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Unsupervised activity	Behavioral: Unsupervised activity; General activity to meet 150 minutes of moderate intensity activity per week
Experimental: Functional Resistance Training (FRT); Supervised, group-based functional resistance training	Other: Functional Resistance Training; Supervised group-based Functional Resistance Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Global Health Status/QoL (subscale of EORTC QLQ-C30, Version 3) scores in cancer survivors	Change in QoL score	Baseline and after the 12-week study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EORTC QLQ-C30 (Overall)	Change in overall QoL score	Baseline and after the 12-week study period
Change in 6 minute walk distance	Improvement in metres walked	Baseline and after the 12-week study period
Change in Lift and carry test performance	Decrease in time taken to complete task	Baseline and after the 12-week study period
Change in Chair stand test performance	Improvement in seat to stand repetitions	Baseline and after the 12-week study period
Change in Handgrip strength score	Improvement in Newtons	Baseline and after the 12-week study period
Change in body mass	Decrease in body mass	Baseline and after the 12-week study period
Change in waist circumference	Decrease in cm	Baseline and after the 12-week study period
Change in body fat %	Decrease in body fat percentage	Baseline and after the 12-week study period
Change in Self-efficacy to regulate exercise scale score	Improvement in self-efifcacy	Baseline and after the 12-week study period

Collaborators and Investigators

• Sponsor: University of Portsmouth
• Collaborators: Portsmouth Hospitals NHS Trust
• Investigators: Study Chair: Andrew T Scott, PhD, University of Portsmouth

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): August 15, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: RETRACE1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No