Effect of Reconditioning Exercise on Older Adults With Urinary Tract Cancer Following Curative Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Reconditioning Exercise on Mobility and Functional Recovery in Older Adults With Urinary Tract Cancer Following Curative Surgery

Conditions
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Rehabilitation

Intervention / Treatment
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* Other: Rehabilitation
* Other: Health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Provide resistance and aerobic exercise | Other: Rehabilitation<br>* Progressive resistance exercise and graded aerobic exercise will be provided for those in the experimental group.<br>|
| Placebo Comparator: Control Group<br>Health education and gross range of motion exercise for upper and lower extremities | Other: Health education<br>* Health education and gross joint range of motion exercise for bilateral upper and lower extremities will be provided for those in the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength of the lower extremities | Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor | Before training | 
| Muscle strength of the lower extremities | Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor | After five-day training | 
| Muscle strength of the lower extremities | Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor | Follow up at one month after training | 
| 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. | Before training | 
| 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. | After five-day training | 
| 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. | Follow up at one month after training | 
| Six minute walk test | Subjects are instructed to walk as far as possible for 6 minutes. | Before training | 
| Six minute walk test | Subjects are instructed to walk as far as possible for 6 minutes. | After five-day training | 
| Six minute walk test | Subjects are instructed to walk as far as possible for 6 minutes. | Follow up at one month after training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Hand grip strength will be measured with a handheld dynamometer. | Before training | 
| Grip strength | Hand grip strength will be measured with a handheld dynamometer. | After five-day training | 
| Grip strength | Hand grip strength will be measured with a handheld dynamometer. | Follow up at one month after training | 
| 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. | Before training | 
| 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. | After five-day training | 
| 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. | Follow up at one month after training | 
| 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. | Before training | 
| 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. | After five-day training | 
| 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. | Follow up at one month after training | 
| 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. | Before training | 
| 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. | After five-day training | 
| 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. | Follow up at one month after training | 
| 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. | Before training | 
| 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. | After five-day training | 
| 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. | Follow up at one month after training |