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

Sponsor
National Cheng Kung University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04999345
Collaborator
(none)
150
1
2
9.3
16.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation
  • Other: Health education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Reconditioning Exercise on Mobility and Functional Recovery in Older Adults With Urinary Tract Cancer Following Curative Surgery
Actual Study Start Date :
Aug 11, 2021
Anticipated Primary Completion Date :
May 20, 2022
Anticipated Study Completion Date :
May 20, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Muscle strength of the lower extremities [Before training]

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

  2. Muscle strength of the lower extremities [After five-day training]

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

  3. Muscle strength of the lower extremities [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 [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 [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 [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 [Before training]

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

  8. Six minute walk test [After five-day training]

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

  9. Six minute walk test [Follow up at one month after training]

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

Secondary Outcome Measures

  1. Grip strength [Before training]

    Hand grip strength will be measured with a handheld dynamometer.

  2. Grip strength [After five-day training]

    Hand grip strength will be measured with a handheld dynamometer.

  3. Grip strength [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 [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 [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 [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 [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 [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 [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) [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) [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) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng Kung University Hospital Tainan city Taiwan

Sponsors and Collaborators

  • National Cheng Kung University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pei-Yun Lee, Assistant professor, National Cheng Kung University
ClinicalTrials.gov Identifier:
NCT04999345
Other Study ID Numbers:
  • A-ER-109-415
First Posted:
Aug 10, 2021
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021