Exercise For Fighting Oncology Repercussions After Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Exercise For Fighting Oncology Repercussions After Treatment: the EFFORT Trial

Conditions
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Neoplasms

Intervention / Treatment
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* Behavioral: Nordic Walking
* Behavioral: Aquatic Exercise
* Behavioral: Functional Exercise Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nordic Walking<br>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<br>* A 12-week Nordic Walking exercise programme supervised twice weekly<br>|
| Experimental: Aquatic Exercise<br>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<br>* A 12-week water-based exercise training programme supervised twice weekly<br>|
| Active Comparator: Functional Exercise Training<br>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<br>* A 12-week circuit-based exercise training programme supervised twice weekly<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Exercise Therapy, Side Effects, Cancer-related Fatigue, Quality of Life