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

Not Applicable

Not yet recruiting

• Conditions: Neoplastic Disease

• Registration Number: NCT06825429
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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).

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-03
• Primary Completion: 2025-07
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency	through study completion, an average of 2 years	The frequency of at least 70% of the exercise sessions foreseen by the programme.
adherence to the group exercise programme	through study completion, an average of 2 years	overall adherence to the group exercise programme \> 40%

Secondary Outcome Measures

Name	Time	Method
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