Neoplastic DiseaseNCT06825429
Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.
A study testing exercise programme for group with ECOG 0-1 and exercise programme for ECOG 2 group in people with Neoplastic Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
The aim of this study to investigate the feasibility in hospital reality, of a group exercise program for oncology patients under active treatment and evaluate its impact on some outcomes considered relevant from both clinical and subjective point of view. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplastic Disease
- What is being tested?
- exercise programme for group with ECOG 0-1 and exercise programme for ECOG 2 group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Sep 2027
- 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
- neoplastic tumor
- age>= 18
- prognosis> 12 months
- ECOG <=2
- Walking with/ without aids
- clinically stable
- signed informed consent
- Patients with bone metastases with ECOG from 0-1 suitable results
Who cannot join
- sensory deficits who cannot perform physical exercise
- cognitive impairment that compromises collaboration and questionnaire filling
- patients with pathologies (e.g. neurological, psychiatric) that do not allow the obtaining of valid informed consent
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
The aim of this study to investigate the feasibility in hospital reality, of a group exercise program for oncology patients under active treatment and evaluate its impact on some outcomes considered relevant from both clinical and subjective point of view.
Read the detailed description
The intervention will consist of EFG sessions lasting 45 minutes each, twice a week for 12 weeks to be carried out in the gym of the Rehabilitation Day Hospital.
Each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises, and will be led by a physiotherapist. The exercises proposed to the group with ECOG 2 will be less intense and of less difficulty with the aim of adapting the activity to patients with a lower performance status (see appendix 4.5, V2, 07/10/2024). The groups will consist of a minimum of five patients and a maximum of ten. Patients will also be stimulated to perform physical activity at home to a total of 150 minutes per week. Patients will be assessed at baseline (T0), at the end of the intervention (T1,12 weeks) and 6 months after the start of the intervention (T2).
- Conditions
- Neoplastic Disease
- Being tested
- exercise programme for group with ECOG 0-1, exercise programme for ECOG 2 group
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise programme for group with ECOG 0-1Procedure or surgery
exercise programme for group with ECOG 2
exercise programme for ECOG 2 groupProcedure or surgery
this intervention shall be proportionated to the ECOG status of the group
| Study group | Role | What they receive |
|---|---|---|
| ECOG 0-1 | Experimental | Each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises and will be led by a physiotherapist Receives: Procedure: exercise programme for group with ECOG 0-1 |
| ECOG 2 | Experimental | The exercises proposed to the group with ECOG 2 will be less intense and less difficult with the aim of adapting the activity to patients with a lower performance status Receives: Procedure: exercise programme for ECOG 2 group |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to the group exercise programme
overall adherence to the group exercise programme > 40%
Measured: through study completion, an average of 2 years
Frequency
The frequency of at least 70% of the exercise sessions foreseen by the programme.
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
QoL
Questionnaire in which patients have to describe quality of life during study treatment
Measured: through study completion, an average of 2 years
tolerance to effort
The effect of the EFG program on mood tone and physical function
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic DiseaseStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, uncontrolled interventional feasibility study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Besa Kopliku, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825429
- Sponsor's protocol ID
- EFG 21/22
- Status last verified
- Dec 2024
- First submitted
- 9 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.
- ClinicalTrials.gov ID
- NCT06825429
- Acronym / sponsor ID
- EFG 21/22
- Conditions
- Neoplastic Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Feb 2025 (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.
The aim of this study to investigate the feasibility in hospital reality, of a group exercise program for oncology patients under active treatment and evaluate its impact on some outcomes considered relevant from both clinical and subjective point of view.
Detailed description
The intervention will consist of EFG sessions lasting 45 minutes each, twice a week for 12 weeks to be carried out in the gym of the Rehabilitation Day Hospital.
Each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises, and will be led by a physiotherapist. The exercises proposed to the group with ECOG 2 will be less intense and of less difficulty with the aim of adapting the activity to patients with a lower performance status (see appendix 4.5, V2, 07/10/2024). The groups will consist of a minimum of five patients and a maximum of ten. Patients will also be stimulated to perform physical activity at home to a total of 150 minutes per week. Patients will be assessed at baseline (T0), at the end of the intervention (T1,12 weeks) and 6 months after the start of the intervention (T2).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centre, uncontrolled interventional feasibility study
| Arm | Type | Receives |
|---|---|---|
| ECOG 0-1 | Experimental | Procedure: exercise programme for group with ECOG 0-1Each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises and will be led by a physiotherapist |
| ECOG 2 | Experimental | Procedure: exercise programme for ECOG 2 groupThe exercises proposed to the group with ECOG 2 will be less intense and less difficult with the aim of adapting the activity to patients with a lower performance status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- neoplastic tumor
- age>= 18
- prognosis> 12 months
- ECOG <=2
- Walking with/ without aids
Key exclusion criteria (3 listed)
- sensory deficits who cannot perform physical exercise
- cognitive impairment that compromises collaboration and questionnaire filling
- patients with pathologies (e.g. neurological, psychiatric) that do not allow the obtaining of valid informed consent
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 |
|---|---|---|
| exercise programme for group with ECOG 0-1exercise programme for group with ECOG 2 | Procedure or surgery | ECOG 0-1 |
| exercise programme for ECOG 2 groupthis intervention shall be proportionated to the ECOG status of the group | Procedure or surgery | ECOG 2 |
Primary outcome
adherence to the group exercise programme
Time frame: through study completion, an average of 2 years
overall adherence to the group exercise programme > 40%
Frequency
Time frame: through study completion, an average of 2 years
The frequency of at least 70% of the exercise sessions foreseen by the programme.
2 secondary outcomes
QoL
Time frame: through study completion, an average of 2 years
tolerance to effort
Time frame: through study completion, an average of 2 years
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 13 Feb 2025.
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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.
Besa Kopliku, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Questions about this trial
What is this clinical trial studying?
A study testing exercise programme for group with ECOG 0-1 and exercise programme for ECOG 2 group in people with Neoplastic Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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 8 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 13 Feb 2025. 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 Besa Kopliku, MD (0512142285, besa.kopliku@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to the group exercise programme (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 13 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.