UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045321 |
|---|---|
| Receipt number | R000051754 |
| Scientific Title | Effect of supervised physical exercise program in early postoperative health-related quality of life among patients with gastrointestinal cancer |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/03/28 08:22:36 |
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Basic information
Public title
Effect of supervised physical exercise program in early postoperative health-related quality of life among patients with gastrointestinal cancer
Acronym
Effect of supervised physical exercise in patients with gastrointestinal cancer
Scientific Title
Effect of supervised physical exercise program in early postoperative health-related quality of life among patients with gastrointestinal cancer
Scientific Title:Acronym
Effect of supervised physical exercise in patients with gastrointestinal cancer
Region
| Japan |
Condition
Condition
Patients with gastrointestinal cancer (gastric cancer, colon cancer and rectal cancer)
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of supervised physical exercise program from discharge to six-weeks after surgery by physical therapist in early postoperative health-related quality of life in patients with gastrointestinal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subscale of health-related QOL (physical functioning): Short-Form 36-Item Health Survey version 2 acute version
Key secondary outcomes
Subscale of health-related QOL (others)
Six-minute walk test
Isometric knee extension force
Grip strength
Body composition
Electromyogram
Muscle oxygen saturation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention will be conducted by a physiotherapist in one session of 60 minutes including items 1-4 and breaks.
1. Evaluation using a six-minute walk test
2. Feedback of evaluation results
3. Resistance training at 20 minutes
4. Aerobic exercise at 20 minutes
The intervention period is from discharge to 6 weeks after surgery. The frequency of intervention should be at least twice a week.
Interventions/Control_2
No treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with no impairment of physical or cognitive function before surgery (full score of Functional Independence Measure).
2. Patient who have no history of orthopedic disease that are expected to have serious effects on activities of daily living.
3. Patient who have no history of nervous disease that are expected to have serious effects on activities of daily living.
4. Patients with no bone metastases.
5. Patients over 18 years.
6. Patients who have obtained written consent from the patient.
7. Patients who are scheduled to have a ileostomy or colostomy in addition to tumor resection before surgery.
Key exclusion criteria
1. Patients with impairment of physical or cognitive function before surgery (full score of Functional Independence Measure).
2. Patient who have history of orthopedic disease that are expected to have serious effects on activities of daily living.
3. Patient who have history of nervous disease that are expected to have serious effects on activities of daily living.
4. Patients with bone metastases.
5. Patients less than 18 years.
6. Patients who have not obtained written consent from the patient.
7. Patients with mental illness.
8. Persons who are judged to be difficult to participate by the attending gastrointestinal surgeon or rehabilitation physician.
9. Persons who underwent ileostomy or colostomy in addition to tumor resection based on findings during surgery.
10. Patients with severe postoperative complications rated grade III or higher in the Clavien-Dindo classification.
11. Patients diagnosed as non-malignant after surgery.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Hara |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Science
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara-shi, Tochigi, Japan
TEL
0287-24-3122
hara@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Hara |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Science
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara-shi, Tochigi, Japan
TEL
0287-24-3122
Homepage URL
hara@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
Research Ethics Board of the International University Health and Welfare
Address
2600-1 Kitakanemaru, Otawara-shi, Tochigi, Japan
Tel
0287-24-3125
s-rinri@iuhw.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
国際医療福祉大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | 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
| 2021 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051754
