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

NCT04999345 | Completed

• 1 other identifier: A-ER-109-415
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (15)

• Grip strength

  Before training

• Grip strength

  After five-day training

• Grip strength

  Follow up at one month after training

• Modified Katz Index of Independence in Activities of Daily Living

  Before training

• Modified Katz Index of Independence in Activities of Daily Living

  After five-day training

Study Arms (2)

Experimental Group

EXPERIMENTAL

Provide resistance and aerobic exercise

Other: Rehabilitation

Control Group

PLACEBO COMPARATOR

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

Other: Health education

Interventions

Rehabilitation OTHER

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

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.

Control Group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pei-Yun Lee, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 10, 2021
• Study Start: August 11, 2021
• Primary Completion: March 20, 2022
• Study Completion: March 14, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)