Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery (APPAHOCA-2)

January 2, 2024 updated by: Centre Francois Baclesse
The aim of this study was to evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

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 Locations

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women aged 65 or over

  • Candidate for scheduled major oncological surgery:

    • Digestive cancer requiring planned surgery with high morbidity, such as esophagectomy, duodenopancreatectomy, total gastrectomy, hepatectomy for cirrhosis, hepatectomy >3 segments, anterior resection of the rectum, partial or total colectomy ± other procedure, ileostomy, extended resection of the small bowel...
    • Upper aerodigestive tract (UADT) cancer candidate for planned pharyngolaryngeal surgery and oral cavity surgery with flap
    • Ovarian, tube or peritoneal cancer
  • Patient able to walk for 10 minutes on the walking platform at the time of the test
  • Patient affiliated to a social security system
  • Signature of informed consent prior to any specific study-related procedure

Exclusion Criteria:

  • Patient with severe undernutrition (BMI<18, and/or weight loss >15% in 6 months or >10% in 1 month)
  • Emergency surgery
  • Physical contraindications preventing use of the platform
  • Simultaneous participation in another clinical study that could compromise the conduct of this study
  • Patients deprived of their liberty, under guardianship or subject to a legal protection measure, or unable to express their consent.
  • Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adapted physical activity
Adapted physical activity on a walking platform
Device: Early rehabilitation through Adapted Physical Activity
From the day after surgery, 1 to 2 walking sessions with walking platform, lasting 6 to 30 minutes (min-max), will be proposed daily until the day of discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.
Time Frame: at hospital discharge (approximately 15 to 30 days after surgery)
Proportion of patients having recovered their preoperative walking speed at hospital discharge
at hospital discharge (approximately 15 to 30 days after surgery)

Collaborators and Investigators

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

Sponsor

Centre Francois Baclesse

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)

February 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01292-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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