Neoplastic Disease
Conditions
Brief 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.
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
PROCEDUREexercise programme for group with ECOG 0-1
exercise programme for group with ECOG 2
PROCEDUREexercise programme for ECOG 2 group
this intervention shall be proportionated to the ECOG status of the group
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single-centre, uncontrolled interventional feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adherence to the group exercise programme | through study completion, an average of 2 years | overall adherence to the group exercise programme \> 40% |
| Frequency | through study completion, an average of 2 years | The frequency of at least 70% of the exercise sessions foreseen by the programme. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL | through study completion, an average of 2 years | Questionnaire in which patients have to describe quality of life during study treatment |
| tolerance to effort | through study completion, an average of 2 years | The effect of the EFG program on mood tone and physical function |
Contacts
Primary ContactBesa Kopliku, MD
Backup ContactLetizia Circosta, PT
Outcome results
None listed