NCT06201884

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Mar 2024

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Mar 2024Dec 2027

First Submitted

Initial submission to the registry

January 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

January 2, 2024

Last Update Submit

January 8, 2026

Conditions

Keywords

Adapted physical activitywalking platform

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Adapted physical activity

EXPERIMENTAL

Adapted physical activity on a walking platform

Device: Early rehabilitation through Adapted Physical Activity

Interventions

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.

Adapted physical activity

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Francois Baclesse

Caen, France

RECRUITING

CHU CAEN

Caen, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 11, 2024

Study Start

March 15, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations