RehabilitationAHTENCT04575220
Adaptive Home Based Pulmonary Tele-exercise
A study testing 12 weeks of bicycle exercise in people with Rehabilitation, run by Leigh Ann Callahan, MD at 1 site in United States.
Trial summary
The goal of this pilot study is to determine if a home based bicycle exercise program can significantly improve the exercise tolerance and well being of pulmonary outpatients. The investigators will use a computer based monitoring system to allow us to speak with participants, view participants, and track patient… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- 12 weeks of bicycle exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 2 Mar 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18-80 years
- previous diagnosis of pulmonary disease, including known chronic pulmonary diseases (COPD, ILD), recent admission for pulmonary disease (pneumonia, asthma, obstructive lung disease), recent ICU discharge for a diagnosis of respiratory failure, and/or previous COVID-19 disease with demonstration of recovery (two negative antigen tests)
- the capacity to perform cycling exercise
Who cannot join
- if the physician caring for the patient determines that the patient should not participate in a home based exercise program
- if the patient has active ischemic cardiac disease
- if the patient's home does not have sufficient space or internet connectivity for the computer and bicycle to be operative
- if the patient is a pregnant female
- if the patient is a prisoner
- if the patient is institutionalized
- if the patient has a terminal clinical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Adaptive Home Based Pulmonary Tele-exercise (AHTE)
The goal of this pilot study is to determine if a home based bicycle exercise program can significantly improve the exercise tolerance and well being of pulmonary outpatients. The investigators will use a computer based monitoring system to allow us to speak with participants, view participants, and track patient bicycle activity (speed, duration of exercise, rate of work) during exercise sessions. The investigators plan to have participants perform three telemonitored exercise sessions per week for 12 weeks as part of this program. The investigators will assess exercise performance on the bicycle, called a work rate test, at the beginning of the program and then again at 6 weeks and 12 weeks into the program to determine if the program can produce a clinically significant improvement in work rate test performance (i.e. a greater than 1.15 minute increase in exercise duration at an 80% work rate). The investigators will also assess participant CRQ, SPPB scores and SF36 scores (indices of patient well being) at baseline, at 6 weeks, and at 12 weeks, to determine if the exercise program elicits an increase in these indices.
Read the detailed description
Studies have shown that pulmonary rehabilitation, which includes exercise and patient education, is a valuable therapy for patients with pulmonary diseases. In fact, pulmonary rehabilitation delivered soon after patient discharge is known to produce a major improvement in patient outcomes. Specifically, studies have shown this intervention reduces readmission rates by 30-70% over the next year. In addition, this therapy improves exercise tolerance, performance of tasks of daily living and sense of patient well being. One study even shows this therapy is 30 times as effective as bronchodilator therapy in improving patient outcomes.
Surprisingly, however, very few pulmonary patients receive pulmonary rehabilitation. Recent studies have shown that 94-98% of discharged pulmonary patients fail to receive this therapy. This pattern has been shown to exist across the United States, with no state demonstrating a much larger use of this therapy. Moreover, use of this therapy is even worse for minorities (only 1% receive pulmonary rehabilitation) and rural populations, such as patients in southern and eastern Kentucky. Several factors are responsible for this failure to employ pulmonary rehabilitation including: (a) very few centers are available and patients cannot realistically travel to the existing centers because of distance, (b) this form of rehabilitation is expensive and patients must pay a large copay (30-50 dollars per session, adding up to a total of 1800 dollars for a typical 12 week program) which many patients cannot afford, (c) centers are only open for restricted hours and working patients cannot miss work to go for rehabilitation, and (d) patients are only eligible for 36 treatment sessions for life.
The purpose of the present project is to define a new home based exercise program that should provide exercise training as good or better than conventional brick and mortar rehabilitation programs. The investigators will use technological advances in home based exercise equipment to both precisely measure participant exercise and to assess physiological improvements over time. This technology will also reduce the expense required to supervise participant training, dramatically reducing costs compared to conventional center based programs. In addition, because programs are home based, the investigators can provide access to participants in rural locations, reduce travel, and easily extend the convenience and schedule of training sessions to accommodate participant lifestyles. While recently there have been a few attempts to provide home based pulmonary rehabilitation programs (e.g. by VA rural health, the Southern Alabama consortium) these other programs do not provide the intensity of training possible with the new paradigm in the current project, are not proven to have the same beneficial effects as conventional center based rehabilitation, and have higher personnel costs making long term financial viability uncertain.
- Conditions
- Rehabilitation
- Being tested
- 12 weeks of bicycle exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks of bicycle exerciseOther
Subjects will conduct monitored exercise, three sessions per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| tele-exercise | Experimental | Subjects will perform three sessions/week of home exercise using bicycles for 12 weeks Receives: Other: 12 weeks of bicycle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
80% work rate test
This will measure changes in the time the subject can exercise at 80% of the maximum work rate.
Measured: This will be measured at baseline, at 6 weeks, and at 12 weeks. The primary outcome measure to be assessed is the change in the 80% work rate test time between the initial and 12 week assessment.
Secondary outcomes (3)
CRQ score: Chronic Respiratory Questionnaire
this will ask how short of breath the subject is: Scores will range from 20 to 140, the higher the score, the better the patient's condition
Measured: baseline and at 6 weeks and 12 weeks
SF36: Short Form Survey; 36 Questions
this questionnaire will ask about quality of life; each question scores from 1 to 6; the higher the score, the worse the patients' condition
Measured: baseline and at 6 weeks and 12 weeks
SPPB: Short Physical Performance Battery
this will test the ability to perform simple movements; balance will be scores 0 to 4, gait speed 2 to 8, and chair standing 0 to 4; the higher the score, the better the patient's condition
Measured: baseline and at 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start20 Oct 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot study evaluating fitness before and after home based rehabilitation
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leigh Ann Callahan, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leigh Ann Callahan, MD, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575220
- Sponsor's protocol ID
- 58756
- Acronym
- AHTE
- Status last verified
- Jun 2023
- First submitted
- 18 Sep 2020
- Last updated
- 7 Jun 2023
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Adaptive Home Based Pulmonary Tele-exercise (AHTE)
- ClinicalTrials.gov ID
- NCT04575220
- Acronym / sponsor ID
- AHTE / 58756
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Leigh Ann Callahan, MDUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 5 Oct 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 goal of this pilot study is to determine if a home based bicycle exercise program can significantly improve the exercise tolerance and well being of pulmonary outpatients. The investigators will use a computer based monitoring system to allow us to speak with participants, view participants, and track patient bicycle activity (speed, duration of exercise, rate of work) during exercise sessions. The investigators plan to have participants perform three telemonitored exercise sessions per week for 12 weeks as part of this program. The investigators will assess exercise performance on the bicycle, called a work rate test, at the beginning of the program and then again at 6 weeks and 12 weeks into the program to determine if the program can produce a clinically significant improvement in work rate test performance (i.e. a greater than 1.15 minute increase in exercise duration at an 80% work rate). The investigators will also assess participant CRQ, SPPB scores and SF36 scores (indices of patient well being) at baseline, at 6 weeks, and at 12 weeks, to determine if the exercise program elicits an increase in these indices.
Detailed description
Studies have shown that pulmonary rehabilitation, which includes exercise and patient education, is a valuable therapy for patients with pulmonary diseases. In fact, pulmonary rehabilitation delivered soon after patient discharge is known to produce a major improvement in patient outcomes. Specifically, studies have shown this intervention reduces readmission rates by 30-70% over the next year. In addition, this therapy improves exercise tolerance, performance of tasks of daily living and sense of patient well being. One study even shows this therapy is 30 times as effective as bronchodilator therapy in improving patient outcomes.
Surprisingly, however, very few pulmonary patients receive pulmonary rehabilitation. Recent studies have shown that 94-98% of discharged pulmonary patients fail to receive this therapy. This pattern has been shown to exist across the United States, with no state demonstrating a much larger use of this therapy. Moreover, use of this therapy is even worse for minorities (only 1% receive pulmonary rehabilitation) and rural populations, such as patients in southern and eastern Kentucky. Several factors are responsible for this failure to employ pulmonary rehabilitation including: (a) very few centers are available and patients cannot realistically travel to the existing centers because of distance, (b) this form of rehabilitation is expensive and patients must pay a large copay (30-50 dollars per session, adding up to a total of 1800 dollars for a typical 12 week program) which many patients cannot afford, (c) centers are only open for restricted hours and working patients cannot miss work to go for rehabilitation, and (d) patients are only eligible for 36 treatment sessions for life.
The purpose of the present project is to define a new home based exercise program that should provide exercise training as good or better than conventional brick and mortar rehabilitation programs. The investigators will use technological advances in home based exercise equipment to both precisely measure participant exercise and to assess physiological improvements over time. This technology will also reduce the expense required to supervise participant training, dramatically reducing costs compared to conventional center based programs. In addition, because programs are home based, the investigators can provide access to participants in rural locations, reduce travel, and easily extend the convenience and schedule of training sessions to accommodate participant lifestyles. While recently there have been a few attempts to provide home based pulmonary rehabilitation programs (e.g. by VA rural health, the Southern Alabama consortium) these other programs do not provide the intensity of training possible with the new paradigm in the current project, are not proven to have the same beneficial effects as conventional center based rehabilitation, and have higher personnel costs making long term financial viability uncertain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot study evaluating fitness before and after home based rehabilitation
| Arm | Type | Receives |
|---|---|---|
| tele-exercise | Experimental | Other: 12 weeks of bicycle exerciseSubjects will perform three sessions/week of home exercise using bicycles for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age from 18-80 years
- previous diagnosis of pulmonary disease, including known chronic pulmonary diseases (COPD, ILD), recent admission for pulmonary disease (pneumonia, asthma, obstructive lung disease), recent ICU discharge for a diagnosis of respiratory failure, and/or previous COVID-19 disease with demonstration of recovery (two negative antigen tests)
- the capacity to perform cycling exercise
Key exclusion criteria (7 listed)
- if the physician caring for the patient determines that the patient should not participate in a home based exercise program
- if the patient has active ischemic cardiac disease
- if the patient's home does not have sufficient space or internet connectivity for the computer and bicycle to be operative
- if the patient is a pregnant female
- if the patient is a prisoner
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 |
|---|---|---|
| 12 weeks of bicycle exerciseSubjects will conduct monitored exercise, three sessions per week for 12 weeks. | Other | tele-exercise |
Primary outcome
80% work rate test
Time frame: This will be measured at baseline, at 6 weeks, and at 12 weeks. The primary outcome measure to be assessed is the change in the 80% work rate test time between the initial and 12 week assessment.
This will measure changes in the time the subject can exercise at 80% of the maximum work rate.
3 secondary outcomes
CRQ score: Chronic Respiratory Questionnaire
Time frame: baseline and at 6 weeks and 12 weeks
SF36: Short Form Survey; 36 Questions
Time frame: baseline and at 6 weeks and 12 weeks
SPPB: Short Physical Performance Battery
Time frame: baseline and at 6 weeks and 12 weeks
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 7 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 weeks of bicycle exercise in people with Rehabilitation, run by Leigh Ann Callahan, MD 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 3 inclusion and 7 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 7 Jun 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 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 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?
80% work rate test (time frame: This will be measured at baseline, at 6 weeks, and at 12 weeks. The primary outcome measure to be assessed is the change in the 80% work rate test time between the initial and 12 week assessment.). 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 7 Jun 2023.