Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery (APPAHOCA-2)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Heidi LAVIEC, MD
- Phone Number: 0231455050
- Email: h.laviec@baclesse.unicancer.fr
Study Locations
-
-
-
Caen, France
- Recruiting
- Centre François Baclesse
-
Contact:
- Heidi LAVIEC, MD
- Email: h.laviec@baclesse.unicancer.fr
-
Caen, France
- Recruiting
- CHU Caen
-
Contact:
- Bérengère BEAUPLET, MD
- Email: b.beauplet@chu-caen.fr
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men or women aged 65 or over
- Candidate for scheduled major oncological surgery and/or surgery with high morbidity
- 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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Adapted physical activity
Adapted physical activity on a walking platform
|
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2023-A01292-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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