Exercise For Fighting Oncology Repercussions After Treatment (EFFORT)

Exercise For Fighting Oncology Repercussions After Treatment: the EFFORT Trial

Cancer survival rates are currently on the verge of 70% at 5 years since diagnosis. Recent improvements in main cancer therapies including chemotherapy, radiotherapy, surgery and immunotherapy as well as developments of new biological therapies have significantly improved survival rates but unfortunately, cancer-related side effects continue to affect many patients even years after completion of main treatments. Exercise has been shown to not only ameliorate cancer-related effects before, during and after treatment but also improve disease-free and overall survival rates by decreasing risk factors associated with cancer risk and improving resilience to treatment. In this non-randomised, three-arm study, we aim to assess the effects of three forms of exercise (i.e: Nordic Walking, Aquatic Exercise and Functional Exercise) on physical performance, cancer-related fatigue, health-related quality of life and cancer-specific symptoms in a wide range of cancer survivors.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Behavioral: Nordic Walking; Behavioral: Aquatic Exercise; Behavioral: Functional Exercise Training

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther Mur Gimeno, PhD; Phone Number: +34931696573; Email: emur@tecnocampus.cat
• Study Contact Backup: Name: Raquel Sebio García, PhD; Phone Number: +34634787194; Email: rsebio@tecnocampus.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults diagnosed with cancer
• Completion of any cancer therapy in the previous 3 months with the exception of hormonal therapy
• Patients living within the Maresme Area
• No contraindications for exercise (oncology clearance or Physical Activity Readiness Questionnaire negative)

Exclusion Criteria:

• Patients with any neurologic, cognitive or musculoskeletal impairments that prevent them to engage in any assessment test or exercise modality.
• Patients with unstable cardiac, respiratory or metabolic diseases
• Unable to speak or read Catalan or Spanish

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Functional Exercise Training; In this group, patients will participate in a traditional, circuit-based exercise training at a fitness facility twice daily during 12 weeks. Each session will consist of: i) 10 min warm up; ii) 40 min of combined resistance and endurance training using a circuit-based structure and iii) 10 min cool-down. Intensity will be monitored with a HR monitor (when available) and/or Borg Scale to reach a moderate intensity for the first 6 weeks (4 - 6 or 55-65% HR reserve) and will progress to moderate-to-high over the following weeks (7-8 or 65-75% HR reserve).	Behavioral: Functional Exercise Training; A 12-week circuit-based exercise training programme supervised twice weekly
Experimental: Nordic Walking; Patients in this arm will be assigned to a 12-week exercise intervention twice weekly based on Nordic Walking (NW). The intervention will be structured as follows: i) 10 min warm-up, ii) 40 min NW with muscle strengthening exercises interspersed in between and iii) 10 min cool-down. Intensity will be monitored with a heart rate monitor (when available) and/or Borg Scale to reach a moderate intensity for the first 6 weeks (4 - 6 or 55-65% HR reserve) to a moderate-to-high intensity the following weeks (7 - 8 or 65-75% HR reserve).	Behavioral: Nordic Walking; A 12-week Nordic Walking exercise programme supervised twice weekly
Experimental: Aquatic Exercise; Patients in this group will be assigned to a 12-week, twice weekly water-based exercise programme to be conducted at a chest-high swimming pool kept around 30 to 32 degrees Celsius. Each session will be structured as previous: i) 10 min warm up; ii) 40 min of combined endurance and strength exercise training and iii) 10 min cool down. Intensity will be monitored using the Borg Scale to be moderate during the first 6 weeks (4 - 6) and moderate-to-high the following 6 weeks (7-8).	Behavioral: Aquatic Exercise; A 12-week water-based exercise training programme supervised twice weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life	HRQoL measured with the EORTC Quality of Life C30 questionnaire	12 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer-related fatigue	Cancer-related fatigue as measure with the Brief Fatigue Inventory	12 weeks from baseline
Cardiorespiratory fitness	A steady state cardiopulmonary exercise testing with breath-by-breath analysis and lactate measurement to determine submaximal cardiorespiratory fitness	12 weeks from baseline
Estimated one-repetition maximum	Estimated maximal muscle strength using a linear Encoder for two main muscle groups: i) chest and ii) quads	12 weeks from baseline
Lower limb muscle endurance	Lower limb muscle endurance measured as the maximum number of sit-to-stand repetitions performed in 30 seconds	12 weeks from baseline
Functional capacity	Walking distance covered during a self-pace 6 minute walk test	12 weeks from baseline

Collaborators and Investigators

• Sponsor: Universitat Pompeu Fabra
• Collaborators: Col·legi de Fisioterapeutes de Catalunya; Ajuntament de Mataró

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Neoplasms; Exercise Therapy; Side Effects; Cancer-related Fatigue
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TCM-EFFORTv3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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