EFFORT: Exercise For Fighting Oncology Repercussions After Treatment

Sponsor

Universitat Pompeu Fabra (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05980325

Collaborator

Col·legi de Fisioterapeutes de Catalunya (Other), Ajuntament de Mataró (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Behavioral: Nordic Walking Behavioral: Aquatic Exercise Behavioral: Functional Exercise Training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Exercise For Fighting Oncology Repercussions After Treatment: the EFFORT Trial

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 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) 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 Exercice 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 30-32ºC. 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
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

Arm

Intervention/Treatment

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 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) 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 Exercice

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 30-32ºC. 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

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

Outcome Measures

Primary Outcome Measures

Health-Related Quality of Life [12 weeks from baseline]
HRQoL measured with the EORTC QLQ C30 questionnaire

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 PAR-Q 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