Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Not yet enrolling

Conditions: Neoplastic Disease

Treatments: Procedure: exercise programme for group with ECOG 0-1; Procedure: exercise programme for ECOG 2 group

Study type: Interventional

Funder types: Other

Identifiers

NCT06825429

EFG 21/22

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

ECOG 0-1

Experimental group

Description:

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

Treatment:

Procedure: exercise programme for group with ECOG 0-1

ECOG 2

Experimental group

Description:

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

Treatment:

Procedure: exercise programme for ECOG 2 group