The Feasibility of Implementing an Exercise Programme for Deconditioned Cancer Survivors

NCT04026659 | Completed

• 1 other identifier: STS19SHE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

As both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Research suggests that exercise can mitigate a number of negative health consequences in cancer survivors and improve physical function and quality of life. Multi-modal exercise interventions have been proposed as a cornerstone for survivorship care. However, studies evaluating exercise programmes within the Irish population are lacking. The aim of the study is to evaluate the introduction, implementation and acceptability of a multi-modal exercise rehabilitation programme for deconditioned cancer survivors in a real-world, standard practice setting.

Conditions

Cancer

Keywords

Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Programme feasibility - recruitment rates as assessed by percentage of eligible study population that consent to participation

  The primary outcome of this study will be its feasibility aspects including recruitment rates (percentage of eligible study population that consent to participation)

  24 weeks

• Programme feasibility - adherence as assessed by the number of prescribed supervised and unsupervised sessions completed by participants

  The primary outcome of this study will be its feasibility aspects including programme adherence (number of prescribed supervised and unsupervised sessions completed by participants)

  24 weeks

• Programme feasibility - retention rates as assessed by the number of participants completing the programme and number of dropouts

  The primary outcome of this study will be its feasibility aspects including programme retention rates (number of participants completing the programme and number of dropouts)

  24 weeks

• Programme feasibility - acceptability of the intervention as assessed by qualitative interviews

  Acceptability of the intervention will be explored through qualitative interviews. Key stakeholders, namely participants in the exercise intervention and health professionals referring to the exercise programme will be invited to participate in semi-structured interviews. Health professionals (n=8-10) referring to the programme will be interviewed to examine their experience of referring to the FIXCAS programme to identify barriers and facilitators to referral and to determine areas for review and further development. Patients (n=10-15) will be asked to evaluate satisfaction with the intervention. Open-ended questions will be used to encourage reflection and elaboration on different aspects of the programme. The interviews will be recorded and transcribed, and data analysis of the interviews will occur through content analysis using simple descriptive thematic analyses.

  24 weeks

Secondary Outcomes (9)

• Change in physical fitness

  Baseline and 10 weeks

• Change in physical activity

  Baseline and 10 weeks

• Change in physical performance

  Baseline and 10 weeks

• Change in lower limb strength

  Baseline and 10 weeks

• Change in Quality of Life (QoL) as assessed by the European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)

  Baseline, 10 weeks, 24 weeks

Study Arms (1)

Multi-modal exercise programme

EXPERIMENTAL

The 10-week multi-modal exercise programme will comprise of twice weekly supervised group-based exercise sessions. Each exercise session will last approximately 1 hour and consist of a combination of aerobic, resistance and balance and flexibility exercises.

Other: Multi-modal exercise

Interventions

Multi-modal exercise OTHER

A combination of aerobic, resistance, balance and flexibility exercises will be included. Aerobic exercise will consist of 20 to 30 min of moderate intensity exercise using a variety of modalities. Heart rate will be monitored using Polar hear rate monitors (target intensity 40-70% heart rate reserve) and the BORG Rating of Perceived Exertion (12-15). Resistance exercise will target the large muscle groups of the upper and lower extremities, be performed at 40% to 70% of the one repetition maximum (1-RM) and consist of two sets of 10-15 repetitions. Flexibility and balance exercise will also be included in the twice weekly programme. A home exercise programme will encourage participants to be moderately physically active for at least 30 minutes, three times per week in addition to the supervised programme.

Multi-modal exercise programme

Eligibility Criteria

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

You may qualify if:

• + years old
• Diagnosis of solid tumour
• Completion of chemotherapy and/or radiotherapy with curative intent within the preceding 2-6 months
• Medically fit to participate in moderate physical activity

You may not qualify if:

• Moderate or severe cognitive impairment
• Current pregnancy
• Individuals receiving treatment in the palliative setting

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Irish Cancer Society: collaborator
• St. James's Hospital, Ireland: collaborator

Study Sites (1)

St. James's Hospital

Dublin, Ireland

Location

Related Publications (1)

• Devenney K, Murphy N, Ryan R, Grant C, Kennedy J, Manecksha RP, Sheils O, McNeely ML, Hussey J, Sheill G. The feasibility of implementing an exercise programme for deconditioned cancer survivors in a national cancer centre: FIXCAS Study. HRB Open Res. 2020 Dec 18;2:24. doi: 10.12688/hrbopenres.12925.2. eCollection 2019.

  PMID: 33870087 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Grainne Sheill, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 19, 2019
• Study Start: September 25, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 31, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)