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

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

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation
• Intervention / Treatment: Other: Rehabilitation; Other: Health education

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan city, Taiwan
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Investigators: Principal Investigator: Pei-Yun Lee, PhD, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): March 20, 2022
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms
• Other Study ID Numbers: A-ER-109-415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No