Clinical trial NCT04999345: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Muscle strength of the lower extremities
timeFrame: Before training
measure: Muscle strength of the lower extremities
timeFrame: After five-day training
measure: Muscle strength of the lower extremities
timeFrame: Follow up at one month after training
measure: Timed up and go test
timeFrame: Before training
measure: Timed up and go test
timeFrame: After five-day training
measure: Timed up and go test
timeFrame: Follow up at one month after training
measure: Six minute walk test
timeFrame: Before training
measure: Six minute walk test
timeFrame: After five-day training
measure: Six minute walk test
timeFrame: Follow up at one month after training
Secondary outcomes:
measure: Grip strength
timeFrame: Before training
measure: Grip strength
timeFrame: After five-day training
measure: Grip strength
timeFrame: Follow up at one month after training
measure: Modified Katz Index of Independence in Activities of Daily Living
timeFrame: Before training
measure: Modified Katz Index of Independence in Activities of Daily Living
timeFrame: After five-day training
measure: Modified Katz Index of Independence in Activities of Daily Living
timeFrame: Follow up at one month after training
measure: Lawton instrumental activities of daily living scale
timeFrame: Before training
measure: Lawton instrumental activities of daily living scale
timeFrame: After five-day training
measure: Lawton instrumental activities of daily living scale
timeFrame: Follow up at one month after training
measure: The Short Portable Mental Status Questionnaire (SPMSQ)
timeFrame: Before training
measure: The Short Portable Mental Status Questionnaire (SPMSQ)
timeFrame: After five-day training
measure: The Short Portable Mental Status Questionnaire (SPMSQ)
timeFrame: Follow up at one month after training
measure: The Short-form Geriatric Depression Scale (GDS)
timeFrame: Before training
measure: The Short-form Geriatric Depression Scale (GDS)
timeFrame: After five-day training
measure: The Short-form Geriatric Depression Scale (GDS)
timeFrame: Follow up at one month after training
Other outcomes:
Locations:
city: Tainan city
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University
name: Pei-Yun Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: