Effect of Reconditioning Exercise on Older Adults With Urinary Tract Cancer Following Curative Surgery
Primary Purpose
Rehabilitation
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Rehabilitation
Health education
Sponsored by
About this trial
This is an interventional treatment trial for Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- after having undergone curative surgery for confirmed urinary tract cancer
- able to independently walk for at least 8 meters before surgery
- able to follow 3-step commands
Exclusion Criteria:
- having unstable medical conditions or metastasis
- having neuromuscular diseases, such as stroke, Parkinson's diseases
- unable to attend training sessions
- having other health issues which would interfere evaluation and exercise training
Sites / Locations
- National Cheng Kung University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Provide resistance and aerobic exercise
Health education and gross range of motion exercise for upper and lower extremities
Outcomes
Primary Outcome Measures
Muscle strength of the lower extremities
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Muscle strength of the lower extremities
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Muscle strength of the lower extremities
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Timed up and go test
Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Timed up and go test
Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Timed up and go test
Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Six minute walk test
Subjects are instructed to walk as far as possible for 6 minutes.
Six minute walk test
Subjects are instructed to walk as far as possible for 6 minutes.
Six minute walk test
Subjects are instructed to walk as far as possible for 6 minutes.
Secondary Outcome Measures
Grip strength
Hand grip strength will be measured with a handheld dynamometer.
Grip strength
Hand grip strength will be measured with a handheld dynamometer.
Grip strength
Hand grip strength will be measured with a handheld dynamometer.
Modified Katz Index of Independence in Activities of Daily Living
Measure independence in basic activities of daily living, including bathing, dressing, toileting, transfers, continence, and feeding. Full score is 32. The lower the score indicates lower dependence in performing daily activities.
Modified Katz Index of Independence in Activities of Daily Living
Measure independence in basic activities of daily living, including bathing, dressing, toileting, transfers, continence, and feeding. Full score is 32. The lower the score indicates lower dependence in performing daily activities.
Modified Katz Index of Independence in Activities of Daily Living
Measure independence in basic activities of daily living, including bathing, dressing, toileting, transfers, continence, and feeding. Full score is 32. The lower the score indicates lower dependence in performing daily activities.
Lawton instrumental activities of daily living scale
To assess more complex activities that allow an individual to live independently in a community, such as shopping, cooking, and managing finances. Full score is 24. The higher the score indicates better function in performing instrumental daily activities.
Lawton instrumental activities of daily living scale
To assess more complex activities that allow an individual to live independently in a community, such as shopping, cooking, and managing finances. Full score is 24. The higher the score indicates better function in performing instrumental daily activities.
Lawton instrumental activities of daily living scale
To assess more complex activities that allow an individual to live independently in a community, such as shopping, cooking, and managing finances. Full score is 24. The higher the score indicates better function in performing instrumental daily activities.
The Short Portable Mental Status Questionnaire (SPMSQ)
To assess cognitive function, including tests of orientation, memory and recall the date, day of the week, place, telephone or address, birth date, current and etc.
The Short Portable Mental Status Questionnaire (SPMSQ)
To assess cognitive function, including tests of orientation, memory and recall the date, day of the week, place, telephone or address, birth date, current and etc.
The Short Portable Mental Status Questionnaire (SPMSQ)
To assess cognitive function, including tests of orientation, memory and recall the date, day of the week, place, telephone or address, birth date, current and etc.
The Short-form Geriatric Depression Scale (GDS)
To measure depression. The scale consists of 15 questions with a full score of 15. Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
The Short-form Geriatric Depression Scale (GDS)
To measure depression. The scale consists of 15 questions with a full score of 15. Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
The Short-form Geriatric Depression Scale (GDS)
To measure depression. The scale consists of 15 questions with a full score of 15. Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Full Information
NCT ID
NCT04999345
First Posted
July 21, 2021
Last Updated
September 9, 2021
Sponsor
National Cheng Kung University
1. Study Identification
Unique Protocol Identification Number
NCT04999345
Brief Title
Effect of Reconditioning Exercise on Older Adults With Urinary Tract Cancer Following Curative Surgery
Official Title
Effectiveness of Reconditioning Exercise on Mobility and Functional Recovery in Older Adults With Urinary Tract Cancer Following Curative Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
May 20, 2022 (Anticipated)
Study Completion Date
May 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
As population ages, geriatric patients with urinary tract cancer suffer from more complications and functional decline that alter treatment plan despite advance in cancer surgery. It was found that these urinary tract cancer survivors required a longer time to recover to the state before the treatment, and some may be even unable to recover to the state before the treatment. Exercise intervention has been found to be beneficial to improve functional capacity for cancer survivors, such as breast cancer. However, it is unclear whether exercise intervention could also improve functional recovery and mobility in patients with urinary tract cancer following curative surgery, especially in older adults. The purpose of this study is to investigate the effect of reconditioning exercise on morbidity, oncological outcomes, and functional recovery in older adults with urinary tract cancer following curative surgery.
Patients aged over 65 years old and after having undergone curative surgery for confirmed urinary tract cancer will be recruited. The participants will be assigned into two groups using blocked randomization design. One group will receive reconditioning exercise training for five consecutive days, and the other group will receive exercise education. Structured questionnaire for comprehensive geriatric assessment and functional mobility, such as walking performance, will be used to assess the training effect. Outcome measures are assessed including major complication after surgeries, changes in functional status, tumor progression, and length of survival. Physical function measurement will include hand grip, muscle strength of lower extremities, and gait performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Provide resistance and aerobic exercise
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Health education and gross range of motion exercise for upper and lower extremities
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Progressive resistance exercise and graded aerobic exercise will be provided for those in the experimental group.
Intervention Type
Other
Intervention Name(s)
Health education
Intervention Description
Health education and gross joint range of motion exercise for bilateral upper and lower extremities will be provided for those in the control group.
Primary Outcome Measure Information:
Title
Muscle strength of the lower extremities
Description
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Time Frame
Before training
Title
Muscle strength of the lower extremities
Description
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Time Frame
After five-day training
Title
Muscle strength of the lower extremities
Description
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Time Frame
Follow up at one month after training
Title
Timed up and go test
Description
Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Time Frame
Before training
Title
Timed up and go test
Description
Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Time Frame
After five-day training
Title
Timed up and go test
Description
Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Time Frame
Follow up at one month after training
Title
Six minute walk test
Description
Subjects are instructed to walk as far as possible for 6 minutes.
Time Frame
Before training
Title
Six minute walk test
Description
Subjects are instructed to walk as far as possible for 6 minutes.
Time Frame
After five-day training
Title
Six minute walk test
Description
Subjects are instructed to walk as far as possible for 6 minutes.
Time Frame
Follow up at one month after training
Secondary Outcome Measure Information:
Title
Grip strength
Description
Hand grip strength will be measured with a handheld dynamometer.
Time Frame
Before training
Title
Grip strength
Description
Hand grip strength will be measured with a handheld dynamometer.
Time Frame
After five-day training
Title
Grip strength
Description
Hand grip strength will be measured with a handheld dynamometer.
Time Frame
Follow up at one month after training
Title
Modified Katz Index of Independence in Activities of Daily Living
Description
Measure independence in basic activities of daily living, including bathing, dressing, toileting, transfers, continence, and feeding. Full score is 32. The lower the score indicates lower dependence in performing daily activities.
Time Frame
Before training
Title
Modified Katz Index of Independence in Activities of Daily Living
Description
Measure independence in basic activities of daily living, including bathing, dressing, toileting, transfers, continence, and feeding. Full score is 32. The lower the score indicates lower dependence in performing daily activities.
Time Frame
After five-day training
Title
Modified Katz Index of Independence in Activities of Daily Living
Description
Measure independence in basic activities of daily living, including bathing, dressing, toileting, transfers, continence, and feeding. Full score is 32. The lower the score indicates lower dependence in performing daily activities.
Time Frame
Follow up at one month after training
Title
Lawton instrumental activities of daily living scale
Description
To assess more complex activities that allow an individual to live independently in a community, such as shopping, cooking, and managing finances. Full score is 24. The higher the score indicates better function in performing instrumental daily activities.
Time Frame
Before training
Title
Lawton instrumental activities of daily living scale
Description
To assess more complex activities that allow an individual to live independently in a community, such as shopping, cooking, and managing finances. Full score is 24. The higher the score indicates better function in performing instrumental daily activities.
Time Frame
After five-day training
Title
Lawton instrumental activities of daily living scale
Description
To assess more complex activities that allow an individual to live independently in a community, such as shopping, cooking, and managing finances. Full score is 24. The higher the score indicates better function in performing instrumental daily activities.
Time Frame
Follow up at one month after training
Title
The Short Portable Mental Status Questionnaire (SPMSQ)
Description
To assess cognitive function, including tests of orientation, memory and recall the date, day of the week, place, telephone or address, birth date, current and etc.
Time Frame
Before training
Title
The Short Portable Mental Status Questionnaire (SPMSQ)
Description
To assess cognitive function, including tests of orientation, memory and recall the date, day of the week, place, telephone or address, birth date, current and etc.
Time Frame
After five-day training
Title
The Short Portable Mental Status Questionnaire (SPMSQ)
Description
To assess cognitive function, including tests of orientation, memory and recall the date, day of the week, place, telephone or address, birth date, current and etc.
Time Frame
Follow up at one month after training
Title
The Short-form Geriatric Depression Scale (GDS)
Description
To measure depression. The scale consists of 15 questions with a full score of 15. Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time Frame
Before training
Title
The Short-form Geriatric Depression Scale (GDS)
Description
To measure depression. The scale consists of 15 questions with a full score of 15. Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time Frame
After five-day training
Title
The Short-form Geriatric Depression Scale (GDS)
Description
To measure depression. The scale consists of 15 questions with a full score of 15. Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time Frame
Follow up at one month after training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
after having undergone curative surgery for confirmed urinary tract cancer
able to independently walk for at least 8 meters before surgery
able to follow 3-step commands
Exclusion Criteria:
having unstable medical conditions or metastasis
having neuromuscular diseases, such as stroke, Parkinson's diseases
unable to attend training sessions
having other health issues which would interfere evaluation and exercise training
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Yun Lee, PhD
Phone
886-6-2353535
Ext
5936
Email
peiyunlee@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Yun Lee, PhD
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan city
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Yun Lee, PhD
Phone
+886-6-2353535
Ext
5936
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Reconditioning Exercise on Older Adults With Urinary Tract Cancer Following Curative Surgery
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