UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053054 |
|---|---|
| Receipt number | R000060347 |
| Scientific Title | Development of a post-discharge tele-rehabilitation system for patients after esophageal cancer surgery: a feasibility study |
| Date of disclosure of the study information | 2023/12/11 |
| Last modified on | 2026/06/14 10:51:47 |
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Basic information
Public title
Development of a post-discharge tele-rehabilitation system for patients after esophageal cancer surgery: a feasibility study
Acronym
Development of a post-discharge tele-rehabilitation system for patients after esophageal cancer surgery: a feasibility study
Scientific Title
Development of a post-discharge tele-rehabilitation system for patients after esophageal cancer surgery: a feasibility study
Scientific Title:Acronym
Development of a post-discharge tele-rehabilitation system for patients after esophageal cancer surgery: a feasibility study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of post-discharge tele-rehabilitation for patients after esophageal cancer surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of implementation of the exercise programme
Key secondary outcomes
Status of implementation of tele-rehabilitation
Health-related quality of life
Functional exercise capacity
Physical activity
Appetite
Weight
Patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Tele-rehabilitation (8 weeks after discharge)
1) Monitoring of physical activity
Evaluation of steps with a wearable device
Monitoring of steps and implementation of voluntary training via an online platform
2) Feedback via video calls and chat messages
Video calls via an online conferencing system (at least once a week)
Real-time counseling via chat messages on an online platform
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who can give their agreement
Persons who have smartphones
Persons who have sufficient understanding of how to use the equipment of the remote system
Key exclusion criteria
Persons who are scheduled to receive postoperative adjuvant therapy requiring hospitalization
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7963
ryokozu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shusuke |
| Middle name | |
| Last name | Toyama |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7963
Homepage URL
hnsnore225@gmail.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Biomedical Sciences Academic Cooperation Division
Address
1-12-4 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
095-819-7195
gakujutu_gakuji@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000060347
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000060347
Number of participants that the trial has enrolled
8
Results
Of 23 eligible patients, 8 were enrolled, and 6 were ultimately included in the analysis. The adherence rates to unsupervised exercise were high, with 100% for resistance training and 88% for endurance training, and no adverse events were observed. However, the dropout rate was 25%. Physical activity increased by a mean of 2,637 steps, and improvements in HRQoL and exercise capacity were also observed. Patient satisfaction was high.
Results date posted
| 2026 | Year | 06 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant characteristics were as follows: age was 68 [34-84] years, 5 patients were male, and BMI was 18.7 [15.9-23.4] kg/m2. Six patients had received neoadjuvant therapy, and the postoperative hospital stay was 39 [20-62] days. The time required to prepare the TR program was 4 [1-8] days.
Participant flow
During the study period, 23 patients were screened, of whom 15 met the exclusion criteria; therefore, 8 patients were included in the study. The reasons for exclusion were as follows: not owning a smartphone in 3 patients, insufficient understanding of how to use the remote system devices in 4 patients, planned postoperative adjuvant therapy requiring hospitalization in 4 patients, and lack of consent in 4 patients.
Adverse events
None
Outcome measures
Adherence to unsupervised exercise, dropout rate from the TR program, incidence of adverse events, physical activity, HRQoL, exercise capacity (CS-30), appetite (CNAQ), body weight, and patient satisfaction.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060347
