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

NCT ID: NCT06825429

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-09-30

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).

Conditions

Neoplastic Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ECOG 0-1

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

Group Type: EXPERIMENTAL

exercise programme for group with ECOG 0-1

Intervention Type: PROCEDURE

exercise programme for group with ECOG 2

ECOG 2

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

Group Type: EXPERIMENTAL

exercise programme for ECOG 2 group

Intervention Type: PROCEDURE

this intervention shall be proportionated to the ECOG status of the group

Interventions

exercise programme for group with ECOG 0-1

exercise programme for group with ECOG 2

Intervention Type: PROCEDURE

exercise programme for ECOG 2 group

this intervention shall be proportionated to the ECOG status of the group

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Besa Kopliku, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Central Contacts

Besa Kopliku, MD

Role: CONTACT

besa.kopliku@aosp.bo.it

0512142285

Letizia Circosta, PT

Role: CONTACT

letizia.circosta@aosp.bo.it

3383394823

Other Identifiers

EFG 21/22

Identifier Type: -

Identifier Source: org_study_id