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NCT05723471 Clinical Trial

Impact of a Collaborative Program of Physical Activity of Newly-diagnosed Cancer Patients

Cancer Clinical Trial

— PROGRESS  

Official title:
Impact of a Collaborative Program of Customized, Adaptive and Supervised Physical Activity on Adherence, Fitness, Quality of Life and Resilience of Newly-diagnosed Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05723471
Other study ID # RC31/21/0600
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2027

Study information
Verified date September 2023
Source University Hospital, Toulouse
Contact Laura BOGDANOVITCH
Phone 0561778437
Email bogdanovitch.l@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During the last twenty years, the cancer overall incidence has been increasing in europe and developed countries, while diagnostic and therapeutic progress have contributes to a reduction in mortality. Currently, almost 4 million people are treated or followed for cancer in France. The physical, psychological and social after-effects are significant. Adaptated physical activity plays an important role in the rehabilitation process. Overall, meta-analyses carried-out with most frequent cancers demonstrate that physical activity practiced would allow an improvement in quality of life, tolerance to anticancer treatments and survival.

Description:

This is a multicenter, two-arm parallel-group randomizes (in a 1:1 ratio), open-label, controlled intervention clinical trial of the comparison of long term adherence to physical activity between an adaptative, customized and collaborative exercise program and standard exercise prescription in patients with newly diagnosed cancer.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 350
Est. completion date December 31, 2027
Est. primary completion date October 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - newly-diagnosed cancer patient - able to start a program of physical activity within the first year follow diagnosis - performance status between 0 to 2 Exclusion Criteria: - uncontrolled cardiovascular disease - peripheral neuropathy grade 3-4 with risk of falling - bone metastasis with risk of bone fracture - platelets <100X109/L - hemoglobin <8g/dL - patient under legal protection

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Adaptative Physical Activity
12 weeks of a collaborative program of customized, adaptative and supervised physical activity by sports instructor

Locations
Country Name City State
France Stéphanie MOTTON Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of physical activity session improvement of long-term adhesion to physical activity 2 years
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