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NCT Number: NCT04999345

Effect of Reconditioning Exercise on 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.

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Key information

Conditions

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

Other

Progressive resistance exercise and graded aerobic exercise will be provided for those in the experimental group.

Health education

Other

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 outcomes

  1. Muscle strength of the lower extremities

    Time frame: Before training

    Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor

  2. Muscle strength of the lower extremities

    Time frame: After five-day training

    Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor

  3. Muscle strength of the lower extremities

    Time frame: Follow up at one month after training

    Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor

  4. Timed up and go test

    Time frame: Before training

    Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.

  5. Timed up and go test

    Time frame: After five-day training

    Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.

  6. Timed up and go test

    Time frame: Follow up at one month after training

    Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.

  7. Six minute walk test

    Time frame: Before training

    Subjects are instructed to walk as far as possible for 6 minutes.

  8. Six minute walk test

    Time frame: After five-day training

    Subjects are instructed to walk as far as possible for 6 minutes.

  9. Six minute walk test

    Time frame: Follow up at one month after training

    Subjects are instructed to walk as far as possible for 6 minutes.

Secondary outcomes

  1. Grip strength

    Time frame: Before training

    Hand grip strength will be measured with a handheld dynamometer.

  2. Grip strength

    Time frame: After five-day training

    Hand grip strength will be measured with a handheld dynamometer.

  3. Grip strength

    Time frame: Follow up at one month after training

    Hand grip strength will be measured with a handheld dynamometer.

  4. Modified Katz Index of Independence in Activities of Daily Living

    Time frame: Before training

    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.

  5. Modified Katz Index of Independence in Activities of Daily Living

    Time frame: After five-day training

    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.

  6. Modified Katz Index of Independence in Activities of Daily Living

    Time frame: Follow up at one month after training

    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.

  7. Lawton instrumental activities of daily living scale

    Time frame: Before training

    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.

  8. Lawton instrumental activities of daily living scale

    Time frame: After five-day training

    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.

  9. Lawton instrumental activities of daily living scale

    Time frame: Follow up at one month after training

    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.

  10. The Short Portable Mental Status Questionnaire (SPMSQ)

    Time frame: Before training

    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.

  11. The Short Portable Mental Status Questionnaire (SPMSQ)

    Time frame: After five-day training

    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.

  12. The Short Portable Mental Status Questionnaire (SPMSQ)

    Time frame: Follow up at one month after training

    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.

  13. The Short-form Geriatric Depression Scale (GDS)

    Time frame: Before training

    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.

  14. The Short-form Geriatric Depression Scale (GDS)

    Time frame: After five-day training

    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.

  15. The Short-form Geriatric Depression Scale (GDS)

    Time frame: Follow up at one month after training

    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.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 10, 2021
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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