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

NCT06825429 | Not Yet Recruiting

• 1 other identifier: EFG 21/22
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neoplastic Disease

Outcome Measures

Primary Outcomes (2)

• adherence to the group exercise programme

  overall adherence to the group exercise programme \> 40%

  through study completion, an average of 2 years

• Frequency

  The frequency of at least 70% of the exercise sessions foreseen by the programme.

  through study completion, an average of 2 years

Secondary Outcomes (2)

• QoL

  through study completion, an average of 2 years

• tolerance to effort

  through study completion, an average of 2 years

Study Arms (2)

ECOG 0-1

EXPERIMENTAL

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

ECOG 2

EXPERIMENTAL

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

Interventions

exercise programme for group with ECOG 0-1 PROCEDURE

exercise programme for group with ECOG 2

ECOG 0-1

exercise programme for ECOG 2 group PROCEDURE

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

ECOG 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Besa Kopliku, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Besa Kopliku, MD

CONTACT

0512142285; besa.kopliku@aosp.bo.it

Letizia Circosta, PT

CONTACT

3383394823; letizia.circosta@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, uncontrolled interventional feasibility study

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 13, 2025

Record last verified: 2024-12