Exercise for Fighting Oncology Repercussions After Treatment

NCT05980325 | Not Yet Recruiting

• 1 other identifier: TCM-EFFORTv3
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neoplasms

Keywords

Neoplasms; Exercise Therapy; Side Effects; Cancer-related Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life

  HRQoL measured with the EORTC Quality of Life C30 questionnaire

  12 weeks from baseline

Secondary Outcomes (5)

• Cancer-related fatigue

  12 weeks from baseline

• Cardiorespiratory fitness

  12 weeks from baseline

• Estimated one-repetition maximum

  12 weeks from baseline

• Lower limb muscle endurance

  12 weeks from baseline

• Functional capacity

  12 weeks from baseline

Study Arms (3)

Nordic Walking

EXPERIMENTAL

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

Aquatic Exercise

EXPERIMENTAL

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

Functional Exercise Training

ACTIVE COMPARATOR

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

Interventions

Nordic Walking BEHAVIORAL

A 12-week Nordic Walking exercise programme supervised twice weekly

Nordic Walking

Aquatic Exercise BEHAVIORAL

A 12-week water-based exercise training programme supervised twice weekly

Aquatic Exercise

Functional Exercise Training BEHAVIORAL

A 12-week circuit-based exercise training programme supervised twice weekly

Functional Exercise Training

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Pompeu Fabra: lead
• Col·legi de Fisioterapeutes de Catalunya: collaborator
• Ajuntament de Mataró: collaborator

MeSH Terms

Conditions

Neoplasms

Interventions

Nordic Walking; Aquatic Therapy

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Central Study Contacts

Esther Mur Gimeno, PhD

CONTACT

+34931696573; emur@tecnocampus.cat

Raquel Sebio García, PhD

CONTACT

+34634787194; rsebio@tecnocampus.cat

Study Design

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

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 8, 2023
• Study Start: January 8, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share