CLINICAL TRIAL

Ambulation for Frailty

Locally Advanced
Recruiting · 18+ · All Sexes · Cleveland, OH

This study is evaluating whether a physical activity program may help lung transplant patients recover more quickly.

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About the trial for Frailty

Eligible Conditions
Lung Graft Dysfunction · Frailty · Transplant-Related Disorder · Sarcopenia · Frail Elderly Syndrome · Mobility Limitation

Treatment Groups

This trial involves 2 different treatments. Ambulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ambulation
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I can speak English fluently. show original
The patient's complete history and physical examination is on file. show original
The person can walk around before the transplant, either with or without help. show original
The participant has signed and dated the informed consent form, indicating that they understand all of the pertinent aspects of the study. show original
Kidney transplant recipients must meet the following inclusion criteria to be included in the study: 1 show original
Have undergone a single or bilateral lung transplant
, the patient had an acute renal failure (ARF) and required renal replacement therapy (RRT) show original
I am active on the list for a single or bilateral lung transplant. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: pre-transplant to 1 year following transplant
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-transplant to 1 year following transplant
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: pre-transplant to 1 year following transplant.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ambulation will improve 3 primary outcomes and 16 secondary outcomes in patients with Frailty. Measurement will happen over the course of Up to 30 days following discharge.

30-day readmission
UP TO 30 DAYS FOLLOWING DISCHARGE
The incidence of readmission to hospital within 30 days of patient discharge from hospital after index lung transplant admission
UP TO 30 DAYS FOLLOWING DISCHARGE
Accelerometer time ambulating
PRE-TRANSPLANT (WEEKS TO A YEAR TO MORE) AND IMMEDIATELY AFTER TRANSPLANT, UP TO 1 YEAR POST-TRANSPLANT
Change in time ambulating from pre-transplant to post-transplant
PRE-TRANSPLANT (WEEKS TO A YEAR TO MORE) AND IMMEDIATELY AFTER TRANSPLANT, UP TO 1 YEAR POST-TRANSPLANT
Accelerometer step change
PRE-TRANSPLANT (WEEKS TO A YEAR TO MORE) AND IMMEDIATELY AFTER TRANSPLANT, UP TO 1 YEAR POST-TRANSPLANT
Change in steps from pre-transplant to post-transplant
PRE-TRANSPLANT (WEEKS TO A YEAR TO MORE) AND IMMEDIATELY AFTER TRANSPLANT, UP TO 1 YEAR POST-TRANSPLANT
Accelerometer energy expenditure
PRE-TRANSPLANT (WEEKS TO A YEAR TO MORE) AND IMMEDIATELY AFTER TRANSPLANT, UP TO 1 YEAR POST-TRANSPLANT
Change in energy expenditure from pre-transplant to post-transplant
PRE-TRANSPLANT (WEEKS TO A YEAR TO MORE) AND IMMEDIATELY AFTER TRANSPLANT, UP TO 1 YEAR POST-TRANSPLANT
Aspiration event
THROUGH STUDY COMPLETION, APPROXIMATELY 1 YEAR POST-TRANSPLANT
Presence of clinical aspiration event during index hospital admission for lung transplant
THROUGH STUDY COMPLETION, APPROXIMATELY 1 YEAR POST-TRANSPLANT
Readmission to ICU
THROUGH STUDY COMPLETION, APPROXIMATELY 1 YEAR POST-TRANSPLANT
Readmission to ICU during index hospitalization for lung transplant
THROUGH STUDY COMPLETION, APPROXIMATELY 1 YEAR POST-TRANSPLANT
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get frailty a year in the United States?

A substantial number of older people, particularly women, could be classified as “at-risk” for frailty. Identifying and treating these individuals will help to prevent disability and chronic diseases among seniors.

Anonymous Patient Answer

Can frailty be cured?

The findings could have important implications regarding the provision of health care to older adults who may require a substantial treatment burden and that they may be treated in the absence of medical urgency.

Anonymous Patient Answer

What causes frailty?

Factors such as comorbidities, age, sex, and education influence a person's risk of frailty. In conclusion, individual and contextual factors must be taken into account for the development of frailty.

Anonymous Patient Answer

What is frailty?

Frailty is associated with an increased risk of death. In men, frailty is associated with accelerated cognitive decline and increased disability in old age. Because the risks of frailty increase in relation to the number of chronic diseases, it is unclear what causes the progression toward frailty.

Anonymous Patient Answer

What are the signs of frailty?

When older patients with multimorbidity receive care in the community, one in five elderly patients and more than four-fifths of elderly patients in long-term care would be classified as having one or more signs of frailty.

Anonymous Patient Answer

What are common treatments for frailty?

Frailty is highly prevalent in a general community setting and the underlying causes are not clear but are likely multifactorial. Frailty may present a target for interventions aiming to improve survivability. However, treatment should focus on preventing further decline.

Anonymous Patient Answer

Have there been any new discoveries for treating frailty?

There have been no medications that were found to be helpful for treating [frailty] with any of the medications discussed. There have also been no studies showing that the drugs can either prevent or treat frailty. Clinicians can only recommend that people have an [older person clinic] on a routine basis to check for other health problems that are not being treated efficiently enough and therefore are causing more of a frailty problem at a later date.

Anonymous Patient Answer

Who should consider clinical trials for frailty?

Frailty as assessed by the frailty scores of the FFI and IADL can identify older persons at an increased risk of being enrolled in clinical trials.

Anonymous Patient Answer

What are the common side effects of ambulation?

Side effects that were frequently reported in this study included dizziness, nausea, and vomiting. Although it is recommended to assess ambulation before the administration of antiemetic agents, caution should be exercised to prevent unnecessary or painful antiemetic application.

Anonymous Patient Answer

What is the average age someone gets frailty?

The average estimate is 70 and 67, for women and men respectively (Fig 2). The age at onset of frailty seems to have been underestimated, especially for men, as most studies reporting the age at onset of frailty were based on self-report and a much larger sample size would be needed to obtain sufficient statistical power.

Anonymous Patient Answer

Has ambulation proven to be more effective than a placebo?

Ambulation is an effective adjunct in reducing the frequency and duration of hospitalizations related to fall-related injuries when used as a part of a comprehensive geriatric intervention.

Anonymous Patient Answer

How does ambulation work?

There are some important issues that are important to consider, which include, the patient's functional status, comorbidities of patient's co-morbidities, patient's functional abilities, gait velocity, and the type of gait velocity measurement. Gait velocity is a useful measurement tool for clinicians and researchers. For rehabilitation clinicians, it can help increase the efficiency of physical therapy interventions. However, it should not be the sole means of determining disability. As there are not many studies that have examined gait velocity, it is extremely crucial to determine functional status and functional abilities prior.

Anonymous Patient Answer
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