FrailtyNCT04241419
A Pilot Study of High Intensity Walking in Older Adults in the Pre-operative Period
A study testing High Intensity Walking in people with Frailty, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate a high intensity walking intervention in older surgical candidates with kidney or thoracic disease and pre-frailty or frailty. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- High Intensity Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 6 Sep 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age or older
- Provision of informed consent
- No obvious contraindication to surgery such as uncontrolled cardiovascular, metabolic, or respiratory disease
- Have either thoracic disease that may require major surgery or End-Stage Renal Disease or Chronic Kidney Disease under consideration for kidney transplant. The kidney transplant patients enrolled must be either a candidate for living donor transplantation or on the expedited deceased donor kidney transplant list, which indicates they are expected to receive an offer in approximately the next 3-5 months.
- Able to ambulate at least 10 feet with moderate assistance (<50% physical assistance)
- Pre-frail or frail on the FRAIL screening tool (1+ positive on this tool)
Who cannot join
- Surgery planned within the 8 week study timeframe
- Uncontrolled cardiovascular, metabolic, or respiratory disease that limits exercise participation
- Resting blood pressure >180/110
- Any pre-existing health condition that would make the subject a poor candidate for this study in the opinion of the PI
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to evaluate a high intensity walking intervention in older surgical candidates with kidney or thoracic disease and pre-frailty or frailty.
Read the detailed description
As the population ages, there are an increasing number of older adults presenting for surgical evaluation. Frailty evaluation has been recognized as a valuable tool in the pre-operative assessment of older adults. Frailty is a clinical syndrome with multiple causes and contributors that involves poor regulation of multiple physiologic systems and is characterized by reduced strength, endurance, and physiologic function. Frailty is a predictor of poor surgical outcomes in older patients, including post-operative complications, increased length of stay, post-discharge institutionalization, and mortality.Identification of frailty in the pre-operative period can aid in risk assessment and decision making for the procedure, can help inform a plan for post-operative care needs, and may provide a target for pre-operative risk reduction interventions.
Given the association of frailty with poor surgical outcomes and the high prevalence of frailty in surgical candidates, there has been much interest in interventions to mitigate this risk. Exercise interventions in other populations have shown success, although the optimal interventions are unknown. In both thoracic surgery and kidney transplantation, there may be a limited amount of time for intervention prior to the operation and patients often have other commitments, such as frequent medical appointments or dialysis sessions. Thus, a short duration program may be beneficial for these populations. High intensity walking is an approach that has shown to lead to functional gains in as short as 12 sessions. The therapists can also modify a high intensity walking program as needed for patients based on physical limitations, making it widely applicable for frail older adults of varying physical function levels, which is important to our older surgical populations. Surgical patients, which include kidney transplant and thoracic surgery patients, are particularly well suited to a pilot high intensity walking intervention given the high proportion of frailty and pre-frailty in these groups.
In this study, the investigator will examine a 12-week high intensity walking program for frail older surgical candidates.
- Conditions
- Frailty
- Being tested
- High Intensity Walking
- Keywords
- ESRD, Thoracic Disease, Kidney Transplant
- Medical subject headings
- Frailty, Kidney Failure, Chronic, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity WalkingBehavioural
Participants will then undergo a 12 session intervention, with two sessions scheduled per week for six weeks. These will be 45 minute sessions, including 15 minutes of a warm-up and cool-down period as well as 30 minutes of walking. The intervention will include various types of over ground walking and stair work.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Walking | Experimental | Participants will then undergo a 12 session intervention, with two sessions scheduled per week for six weeks. These will be 45 minute sessions, including 15 minutes of a warm-up and cool-down period as well as 30 minutes of walking. The intervention will include various types of over ground walking and stair work. Receives: Behavioral: High Intensity Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic Frailty Criteria
The phenotypic frailty criteria is a validated frailty measurement tool. Phenotypic frailty is a composite that includes grip strength measured via a dynamometer, self-reported weight loss, self-reported exhaustion using a validated two question screen, 15 foot gait speed, and activity level measured by the Minnesota Leisure Time Physical Activity Questionnaire. This will be measured at baseline and 8 weeks.
Measured: 8 weeks
Secondary outcomes (4)
Short Physical Performance Battery (SPPB)
The SPPB is a mobility assessment which includes gait speed, sit to stand testing, and balance assessment. This will be measured at baseline and 8 weeks.
Measured: 8 weeks
Berg Balance Scale
The Berg balance scale will be used to assess the subject's balance at baseline and 8 weeks.
Measured: 8 weeks
6 minute walk test
The distance a subject can walk in 6 minutes will be measured at baseline and 8 weeks.
Measured: 8 weeks
PROMIS Global Health
The PROMIS Global Health tool measures patient reported physical, mental, and social health, pain, and quality of life. This will be measured at baseline and 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 May 2019
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Why it stopped: Unaware that the devices being used had a shelf life of only 6 months, the physical therapist could no longer assist with the study and did not have anyone to run the physical therapy aspect of the program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria L Madariaga, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241419
- Sponsor's protocol ID
- IRB19-0468
- Status last verified
- Oct 2024
- First submitted
- 22 Jan 2020
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of High Intensity Walking in Older Adults in the Pre-operative Period
- ClinicalTrials.gov ID
- NCT04241419
- Acronym / sponsor ID
- IRB19-0468
- Conditions
- Frailty
- Keywords
- ESRD, Thoracic Disease, Kidney Transplant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unaware that the devices being used had a shelf life of only 6 months, the physical therapist could no longer assist with the study and did not have anyone to run the physical therapy aspect of the program.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 27 Jan 2020 (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.
The purpose of this pilot study is to evaluate a high intensity walking intervention in older surgical candidates with kidney or thoracic disease and pre-frailty or frailty.
Detailed description
As the population ages, there are an increasing number of older adults presenting for surgical evaluation. Frailty evaluation has been recognized as a valuable tool in the pre-operative assessment of older adults. Frailty is a clinical syndrome with multiple causes and contributors that involves poor regulation of multiple physiologic systems and is characterized by reduced strength, endurance, and physiologic function. Frailty is a predictor of poor surgical outcomes in older patients, including post-operative complications, increased length of stay, post-discharge institutionalization, and mortality.Identification of frailty in the pre-operative period can aid in risk assessment and decision making for the procedure, can help inform a plan for post-operative care needs, and may provide a target for pre-operative risk reduction interventions.
Given the association of frailty with poor surgical outcomes and the high prevalence of frailty in surgical candidates, there has been much interest in interventions to mitigate this risk. Exercise interventions in other populations have shown success, although the optimal interventions are unknown. In both thoracic surgery and kidney transplantation, there may be a limited amount of time for intervention prior to the operation and patients often have other commitments, such as frequent medical appointments or dialysis sessions. Thus, a short duration program may be beneficial for these populations. High intensity walking is an approach that has shown to lead to functional gains in as short as 12 sessions. The therapists can also modify a high intensity walking program as needed for patients based on physical limitations, making it widely applicable for frail older adults of varying physical function levels, which is important to our older surgical populations. Surgical patients, which include kidney transplant and thoracic surgery patients, are particularly well suited to a pilot high intensity walking intervention given the high proportion of frailty and pre-frailty in these groups.
In this study, the investigator will examine a 12-week high intensity walking program for frail older surgical candidates.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Intensity Walking | Experimental | Behavioral: High Intensity WalkingParticipants will then undergo a 12 session intervention, with two sessions scheduled per week for six weeks. These will be 45 minute sessions, including 15 minutes of a warm-up and cool-down period as well as 30 minutes of walking. The intervention will include various types of over ground walking and stair work. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 60 years of age or older
- Provision of informed consent
- No obvious contraindication to surgery such as uncontrolled cardiovascular, metabolic, or respiratory disease
- Have either thoracic disease that may require major surgery or End-Stage Renal Disease or Chronic Kidney Disease under consideration for kidney transplant. The kidney transplant patients enrolled must be either a candidate for living donor transplantation or on the expedited deceased donor kidney transplant list, which indicates they are expected to receive an offer in approximately the next 3-5 months.
- Able to ambulate at least 10 feet with moderate assistance (<50% physical assistance)
Key exclusion criteria (4 listed)
- Surgery planned within the 8 week study timeframe
- Uncontrolled cardiovascular, metabolic, or respiratory disease that limits exercise participation
- Resting blood pressure >180/110
- Any pre-existing health condition that would make the subject a poor candidate for this study in the opinion of the PI
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 |
|---|---|---|
| High Intensity WalkingParticipants will then undergo a 12 session intervention, with two sessions scheduled per week for six weeks. These will be 45 minute sessions, including 15 minutes of a warm-up and cool-down period as well as 30 minutes of walking. The intervention will include various types of over ground walking and stair work. | Behavioural | High Intensity Walking |
Primary outcome
Phenotypic Frailty Criteria
Time frame: 8 weeks
The phenotypic frailty criteria is a validated frailty measurement tool. Phenotypic frailty is a composite that includes grip strength measured via a dynamometer, self-reported weight loss, self-reported exhaustion using a validated two question screen, 15 foot gait speed, and activity level measured by the Minnesota Leisure Time Physical Activity Questionnaire. This will be measured at baseline and 8 weeks.
4 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: 8 weeks
Berg Balance Scale
Time frame: 8 weeks
6 minute walk test
Time frame: 8 weeks
PROMIS Global Health
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Unaware that the devices being used had a shelf life of only 6 months, the physical therapist could no longer assist with the study and did not have anyone to run the physical therapy aspect of the program.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- 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.
Maria L Madariaga, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Walking in people with Frailty, run by University of Chicago at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 23 Oct 2024. 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 United States. 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. 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 was stopped early (reason given: Unaware that the devices being used had a shelf life of only 6 months, the physical therapist could no longer assist with the study and did not have anyone to run the physical therapy aspect of the program.). Results are not available in the source record.
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?
Phenotypic Frailty Criteria (time frame: 8 weeks). 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 23 Oct 2024.