Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: exercise programme for group with ECOG 0-1, exercise programme for ECOG 2 group.
- Who it may be relevant to
- Registry conditions: Neoplastic Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Procedure exercise programme for group with ECOG 0-1
exercise programme for group with ECOG 2 - Procedure exercise programme for ECOG 2 group
this intervention shall be proportionated to the ECOG status of the group
Primary outcome measures
- adherence to the group exercise programme [Time frame: through study completion, an average of 2 years]
- Frequency [Time frame: through study completion, an average of 2 years]
Secondary outcome measures (2)
- QoL [Time frame: through study completion, an average of 2 years]
- tolerance to effort [Time frame: through study completion, an average of 2 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06825429 · EFG 21/22