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

NCT ID: NCT04999345

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2023-03-14

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.

Detailed Description

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Conditions

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Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

Provide resistance and aerobic exercise

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type OTHER

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

Control Group

Health education and gross range of motion exercise for upper and lower extremities

Group Type PLACEBO_COMPARATOR

Health education

Intervention Type 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.

Interventions

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Rehabilitation

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

Intervention Type 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.

Intervention Type OTHER

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Pei-Yun Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pei-Yun Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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A-ER-109-415

Identifier Type: -

Identifier Source: org_study_id