Colorectal CancerRETRACENCT02889276
Effects of Functional Exercise on Fitness and QoL in Cancer Survivors
A study testing Functional Resistance Training and Unsupervised activity in people with Colorectal Cancer, run by University of Portsmouth at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Functional Resistance Training and Unsupervised activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Colorectal Cancer
- Being tested
- Functional Resistance Training, Unsupervised activity
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Resistance TrainingOther
Supervised group-based Functional Resistance Training
Unsupervised activityBehavioural
General activity to meet 150 minutes of moderate intensity activity per week
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Unsupervised activity Receives: Behavioral: Unsupervised activity |
| Functional Resistance Training (FRT) | Experimental | Supervised, group-based functional resistance training Receives: Other: Functional Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Health Status/QoL (subscale of EORTC QLQ-C30, Version 3) scores in cancer survivors
Change in QoL score
Measured: Baseline and after the 12-week study period
Secondary outcomes (9)
Change in EORTC QLQ-C30 (Overall)
Change in overall QoL score
Measured: Baseline and after the 12-week study period
Change in 6 minute walk distance
Improvement in metres walked
Measured: Baseline and after the 12-week study period
Change in Lift and carry test performance
Decrease in time taken to complete task
Measured: Baseline and after the 12-week study period
Change in Chair stand test performance
Improvement in seat to stand repetitions
Measured: Baseline and after the 12-week study period
Change in Handgrip strength score
Improvement in Newtons
Measured: Baseline and after the 12-week study period
Change in body mass
Decrease in body mass
Measured: Baseline and after the 12-week study period
Change in waist circumference
Decrease in cm
Measured: Baseline and after the 12-week study period
Change in body fat %
Decrease in body fat percentage
Measured: Baseline and after the 12-week study period
Change in Self-efficacy to regulate exercise scale score
Improvement in self-efifcacy
Measured: Baseline and after the 12-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start20 Feb 2017
- Primary completion15 Aug 2017
- Study completion30 Aug 2017
Why it stopped: Only 4 participants were recruited from 130 potential participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Responsible party
- Principal investigator, Andrew Scott, University of Portsmouth
- Investigators
- Andrew T Scott, PhD, Study chair, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889276
- Sponsor's protocol ID
- RETRACE1
- Acronym
- RETRACE
- Status last verified
- Mar 2020
- First submitted
- 19 Aug 2016
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Functional Resistance Training Programme on Physical Fitness and Health-related Quality of Life in Colorectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT02889276
- Acronym / sponsor ID
- RETRACE / RETRACE1
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 4 participants were recruited from 130 potential participants.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Unsupervised activityUnsupervised activity |
| Functional Resistance Training (FRT) | Experimental | Other: Functional Resistance TrainingSupervised, group-based functional resistance training |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Resistance TrainingSupervised group-based Functional Resistance Training | Other | Functional Resistance Training (FRT) |
| Unsupervised activityGeneral activity to meet 150 minutes of moderate intensity activity per week | Behavioural | Control |
Primary outcome
Change in Global Health Status/QoL (subscale of EORTC QLQ-C30, Version 3) scores in cancer survivors
Time frame: Baseline and after the 12-week study period
Change in QoL score
9 secondary outcomes
Change in EORTC QLQ-C30 (Overall)
Time frame: Baseline and after the 12-week study period
Change in 6 minute walk distance
Time frame: Baseline and after the 12-week study period
Change in Lift and carry test performance
Time frame: Baseline and after the 12-week study period
Change in Chair stand test performance
Time frame: Baseline and after the 12-week study period
Change in Handgrip strength score
Time frame: Baseline and after the 12-week study period
Change in body mass
Time frame: Baseline and after the 12-week study period
Change in waist circumference
Time frame: Baseline and after the 12-week study period
Change in body fat %
Time frame: Baseline and after the 12-week study period
Change in Self-efficacy to regulate exercise scale score
Time frame: Baseline and after the 12-week study period
Results and safety
The study was stopped early (reason given: Only 4 participants were recruited from 130 potential participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew T Scott, PhD study chair
University of Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Resistance Training and Unsupervised activity in people with Colorectal Cancer, run by University of Portsmouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only 4 participants were recruited from 130 potential participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Health Status/QoL (subscale of EORTC QLQ-C30, Version 3) scores in cancer survivors (time frame: Baseline and after the 12-week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.