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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05980325
Other study ID # TCM-EFFORTv3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date July 1, 2025

Study information

Verified date August 2023
Source Universitat Pompeu Fabra
Contact Esther Mur Gimeno, PhD
Phone +34931696573
Email emur@tecnocampus.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date July 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nordic Walking
A 12-week Nordic Walking exercise programme supervised twice weekly
Aquatic Exercise
A 12-week water-based exercise training programme supervised twice weekly
Functional Exercise Training
A 12-week circuit-based exercise training programme supervised twice weekly

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Universitat Pompeu Fabra Ajuntament de Mataró, Col·legi de Fisioterapeutes de Catalunya

Outcome

Type Measure Description Time frame Safety issue
Primary Health-Related Quality of Life HRQoL measured with the EORTC Quality of Life C30 questionnaire 12 weeks from baseline
Secondary Cancer-related fatigue Cancer-related fatigue as measure with the Brief Fatigue Inventory 12 weeks from baseline
Secondary 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
Secondary 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
Secondary 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
Secondary Functional capacity Walking distance covered during a self-pace 6 minute walk test 12 weeks from baseline
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