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

February 11, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: exercise programme for group with ECOG 0-1
exercise programme for group with ECOG 2
Experimental: 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
Procedure: exercise programme for ECOG 2 group
this intervention shall be proportionated to the ECOG status of the group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence to the group exercise programme
Time Frame: through study completion, an average of 2 years
overall adherence to the group exercise programme > 40%
through study completion, an average of 2 years
Frequency
Time Frame: through study completion, an average of 2 years
The frequency of at least 70% of the exercise sessions foreseen by the programme.
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL
Time Frame: through study completion, an average of 2 years
Questionnaire in which patients have to describe quality of life during study treatment
through study completion, an average of 2 years
tolerance to effort
Time Frame: through study completion, an average of 2 years
The effect of the EFG program on mood tone and physical function
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Besa Kopliku, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFG 21/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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