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NCT Number: NCT06825429

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise programme for group with ECOG 0-1

Procedure

exercise programme for group with ECOG 2

exercise programme for ECOG 2 group

Procedure

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

Primary outcomes

  1. adherence to the group exercise programme

    Time frame: through study completion, an average of 2 years

    overall adherence to the group exercise programme > 40%

  2. 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.

Secondary outcomes

  1. QoL

    Time frame: through study completion, an average of 2 years

    Questionnaire in which patients have to describe quality of life during study treatment

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Besa Kopliku, MD

CONTACT

[email protected]

0512142285

Letizia Circosta, PT

CONTACT

[email protected]

3383394823

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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