NeoplasmsEFFORTNCT05980325
Exercise for Fighting Oncology Repercussions After Treatment
A study testing Nordic Walking, Aquatic Exercise and Functional Exercise Training in people with Neoplasms, run by Universitat Pompeu Fabra.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Nordic Walking, Aquatic Exercise and Functional Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Neoplasms
- Being tested
- Nordic Walking, Aquatic Exercise, Functional Exercise Training
- Keywords
- Neoplasms, Exercise Therapy, Side Effects, Cancer-related Fatigue, Quality of Life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic WalkingBehavioural
A 12-week Nordic Walking exercise programme supervised twice weekly
Aquatic ExerciseBehavioural
A 12-week water-based exercise training programme supervised twice weekly
Functional Exercise TrainingBehavioural
A 12-week circuit-based exercise training programme supervised twice weekly
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Behavioral: Functional Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
HRQoL measured with the EORTC Quality of Life C30 questionnaire
Measured: 12 weeks from baseline
Secondary outcomes (5)
Cancer-related fatigue
Cancer-related fatigue as measure with the Brief Fatigue Inventory
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks from baseline
Functional capacity
Walking distance covered during a self-pace 6 minute walk test
Measured: 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start8 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Collaborators
- Col·legi de Fisioterapeutes de Catalunya, Ajuntament de Mataró
- Responsible party
- Principal investigator, Raquel Sebio, Universitat Pompeu Fabra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980325
- Sponsor's protocol ID
- TCM-EFFORTv3
- Acronym
- EFFORT
- Status last verified
- Dec 2024
- First submitted
- 28 Jul 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise for Fighting Oncology Repercussions After Treatment: the EFFORT Trial
- ClinicalTrials.gov ID
- NCT05980325
- Acronym / sponsor ID
- EFFORT / TCM-EFFORTv3
- Conditions
- Neoplasms
- Keywords
- Neoplasms, Exercise Therapy, Side Effects, Cancer-related Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Collaborators
- Col·legi de Fisioterapeutes de Catalunya, Ajuntament de Mataró
- Study start
- 8 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nordic Walking | Experimental | Behavioral: Nordic WalkingPatients 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). |
| Aquatic Exercise | Experimental | Behavioral: Aquatic ExercisePatients 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). |
| Functional Exercise Training | Active comparator | Behavioral: Functional Exercise TrainingIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic WalkingA 12-week Nordic Walking exercise programme supervised twice weekly | Behavioural | Nordic Walking |
| Aquatic ExerciseA 12-week water-based exercise training programme supervised twice weekly | Behavioural | Aquatic Exercise |
| Functional Exercise TrainingA 12-week circuit-based exercise training programme supervised twice weekly | Behavioural | Functional Exercise Training |
Primary outcome
Health-Related Quality of Life
Time frame: 12 weeks from baseline
HRQoL measured with the EORTC Quality of Life C30 questionnaire
5 secondary outcomes
Cancer-related fatigue
Time frame: 12 weeks from baseline
Cardiorespiratory fitness
Time frame: 12 weeks from baseline
Estimated one-repetition maximum
Time frame: 12 weeks from baseline
Lower limb muscle endurance
Time frame: 12 weeks from baseline
Functional capacity
Time frame: 12 weeks from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic Walking, Aquatic Exercise and Functional Exercise Training in people with Neoplasms, run by Universitat Pompeu Fabra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther Mur Gimeno, PhD (+34931696573, emur@tecnocampus.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.