Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery

Surgery Clinical Trial

— APPAHOCA-2  

Official title:

Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06201884
• Other study ID #: 2023-A01292-43
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2024
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Centre Francois Baclesse
• Contact: Heidi LAVIEC, MD
• Phone: 0231455050
• Email: h.laviec[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly Patients
• Neoplasms
• Oncology
• Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Centre Francois Baclesse	Caen
France	CHU CAEN	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Proportion of patients having recovered their preoperative walking speed at hospital discharge	at hospital discharge (approximately 15 to 30 days after surgery)