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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06201884
Other study ID # 2023-A01292-43
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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