Effects of Functional Exercise on Fitness and QoL in Cancer Survivors

NCT02889276 | Terminated DMC

• 1 other identifier: RETRACE1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in EORTC QLQ-C30 (Overall)

  Baseline and after the 12-week study period

• Change in 6 minute walk distance

  Baseline and after the 12-week study period

• Change in Lift and carry test performance

  Baseline and after the 12-week study period

• Change in Chair stand test performance

  Baseline and after the 12-week study period

• Change in Handgrip strength score

  Baseline and after the 12-week study period

Study Arms (2)

Control

ACTIVE COMPARATOR

Unsupervised activity

Behavioral: Unsupervised activity

Functional Resistance Training (FRT)

EXPERIMENTAL

Supervised, group-based functional resistance training

Other: Functional Resistance Training

Interventions

Functional Resistance Training OTHER

Supervised group-based Functional Resistance Training

Functional Resistance Training (FRT)

Unsupervised activity BEHAVIORAL

General activity to meet 150 minutes of moderate intensity activity per week

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Portsmouth: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (1)

Andrew Scott

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Andrew T Scott, PhD

  University of Portsmouth

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 5, 2016
• Study Start: February 20, 2017
• Primary Completion: August 15, 2017
• Study Completion: August 30, 2017
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)