RehabilitationNCT04999345
Effect of Reconditioning Exercise on Older Adults With Urinary Tract Cancer Following Curative Surgery
A study testing Rehabilitation and Health education in people with Rehabilitation, run by National Cheng Kung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Rehabilitation and Health education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Aug 2021to 14 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rehabilitation
- Being tested
- Rehabilitation, Health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Progressive resistance exercise and graded aerobic exercise will be provided for those in the experimental group.
Health educationOther
Health education and gross joint range of motion exercise for bilateral upper and lower extremities will be provided for those in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Provide resistance and aerobic exercise Receives: Other: Rehabilitation |
| Control Group | Placebo comparator | Health education and gross range of motion exercise for upper and lower extremities Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength of the lower extremities
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Measured: Before training
Muscle strength of the lower extremities
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Measured: After five-day training
Muscle strength of the lower extremities
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow up at one month after training
Six minute walk test
Subjects are instructed to walk as far as possible for 6 minutes.
Measured: Before training
Six minute walk test
Subjects are instructed to walk as far as possible for 6 minutes.
Measured: After five-day training
Six minute walk test
Subjects are instructed to walk as far as possible for 6 minutes.
Measured: Follow up at one month after training
Secondary outcomes (15)
Grip strength
Hand grip strength will be measured with a handheld dynamometer.
Measured: Before training
Grip strength
Hand grip strength will be measured with a handheld dynamometer.
Measured: After five-day training
Grip strength
Hand grip strength will be measured with a handheld dynamometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow up at one month after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start11 Aug 2021
- Primary completion20 Mar 2022
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Yun Lee, National Cheng Kung University
- Investigators
- Pei-Yun Lee, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999345
- Sponsor's protocol ID
- A-ER-109-415
- Status last verified
- Nov 2023
- First submitted
- 21 Jul 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Reconditioning Exercise on Mobility and Functional Recovery in Older Adults With Urinary Tract Cancer Following Curative Surgery
- ClinicalTrials.gov ID
- NCT04999345
- Acronym / sponsor ID
- A-ER-109-415
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: RehabilitationProvide resistance and aerobic exercise |
| Control Group | Placebo comparator | Other: Health educationHealth education and gross range of motion exercise for upper and lower extremities |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationProgressive resistance exercise and graded aerobic exercise will be provided for those in the experimental group. | Other | Experimental Group |
| Health educationHealth education and gross joint range of motion exercise for bilateral upper and lower extremities will be provided for those in the control group. | Other | Control Group |
Primary outcome
Muscle strength of the lower extremities
Time frame: Before training
Muscle strength of bilateral hip flexor,knee extensor, ankle dorsiflexor, and ankle plantarflexor
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
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
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.
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.
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.
Six minute walk test
Time frame: Before training
Subjects are instructed to walk as far as possible for 6 minutes.
Six minute walk test
Time frame: After five-day training
Subjects are instructed to walk as far as possible for 6 minutes.
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.
15 secondary outcomes
Grip strength
Time frame: Before training
Grip strength
Time frame: After five-day training
Grip strength
Time frame: Follow up at one month after training
Modified Katz Index of Independence in Activities of Daily Living
Time frame: Before training
Modified Katz Index of Independence in Activities of Daily Living
Time frame: After five-day training
Modified Katz Index of Independence in Activities of Daily Living
Time frame: Follow up at one month after training
Lawton instrumental activities of daily living scale
Time frame: Before training
Lawton instrumental activities of daily living scale
Time frame: After five-day training
Lawton instrumental activities of daily living scale
Time frame: Follow up at one month after training
The Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: Before training
The Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: After five-day training
The Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: Follow up at one month after training
The Short-form Geriatric Depression Scale (GDS)
Time frame: Before training
The Short-form Geriatric Depression Scale (GDS)
Time frame: After five-day training
The Short-form Geriatric Depression Scale (GDS)
Time frame: Follow up at one month after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Yun Lee, PhD principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation and Health education in people with Rehabilitation, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength of the lower extremities (time frame: Before training). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.