Corona Virus InfectionNCT04821531
Feasibility of a Self-guided Exercise Program Among Hospitalized COVID-19 Patients
A study testing PT Pal and Exercise Manual in people with Corona Virus Infection, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The investigators' aim is to conduct a study looking into safety and feasibility study of Covid patients participating in a self-guided exercises program while admitted to the hospital. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- PT Pal and Exercise Manual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2021to Dec 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 Positive by PCR testing
- Adults aged 50-75
- Patients evaluated by Rehabilitation team and found appropriate for the study
- Able to read and understand English or Spanish
- Have access to a smartphone
Who cannot join
- Pregnant patients
- Patients with dementia or cognitive dysfunction
- Patients who exhibit poor safety or unsafe behavior
- Patients who need high flow oxygen, rebreather or any form of ventilatory support
- Patients with chest tubes or similar attachments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Adding a Self-guided Exercise Program on Functional Outcomes Among Hospitalized COVID-19 Patients: A Randomized Prospective Study
The investigators' aim is to conduct a study looking into safety and feasibility study of Covid patients participating in a self-guided exercises program while admitted to the hospital. The investigators will test 2 forms of exercise instruction, one using an exercise phone-based application, and the other a printed exercise manual.
Read the detailed description
The COVID-19 pandemic has resulted in significant morbidity and mortality throughout the world. As of March 16, 2021 there were over 119 million confirmed COVID-19 cases and 2.6 million deaths globally. The majority of COVID-19 cases are mild to moderate, resulting in symptom resolution within 6 weeks of symptom onset.
Following moderate to severe COVID-19 infections, functional impairments are likely to be dominated by peripheral muscle dysfunction (due to deconditioning and decreased lean body mass, ICU neuropathy, fatigue and the effects of hypoxemia), respiratory muscle dysfunction (dysfunctional breathing pattern, DBP, and exercise-induced laryngeal obstruction), cardiac impairment and deconditioning, and psychosocial factors (anxiety, depression, guilt, sleep disturbance and dependency).
Physical exercise has proven to be an effective therapy for most chronic diseases and microbial infections with preventive or therapeutic benefits involving the primary immunological mediators and/or anti-inflammatory properties. Another mechanism is that it can counteract the effect of prolonged bedrest by preventing the decline in muscle strength, muscle mass loss , reduce exaggerated cardiac response to exercise, reduce thromboembolism, and improve lung function. Prior research in COPD patients have shown that early pulmonary rehabilitation showed reductions in mortality, length of stay and readmission.
There has been some concern among physicians about allowing patients with COVID-19 to exercise. This is also of concern to all practitioners of Rehabilitation Medicine and the investigators seek to understand the risks better. This research group is currently concluding another retrospective study of 988 COVID-19 patients that suggest that not only is exercise safe, but increasing the number of exercise interventions improves the functional status of the patients and may reduce mortality.
As the next step, the investigators propose a 12-month, single blind feasibility study to determine if adding a self-guided exercise to a patient population already receiving two 30-minutes/week therapy can improve the patient's overall functional and cognitive outcomes. The overall hypothesis is that COVID-19 patients admitted to the hospital with mild to moderate disease can safely perform these exercises and improve their physical and cognitive functioning. The objective in performing this study is to examine feasibility as well as obtain preliminary data to design future RCT studies in this or other similar diseases. The self-guided exercise program was developed by the Department of Rehabilitation at Montefiore during the initial COVID-19 surge. The manual has been published in the Journal for the International Society of Physical and Rehabilitation Medicine and has been distributed through many medical society websites. COVID-19 patients admitted to the Montefiore Hospital have been receiving the exercise manual upon discharge for the past 9 months. The exercises in the program are divided into 3 levels. The initial level focuses on prevention of lung complication associated with COVID-19, and prevention of contracture in the large joints associated with bedrest. The next level focuses on improving sitting tolerance, strengthening limb and accessory muscles of breathing. The final level works on standing balance, large muscle strengthening, and building cardiopulmonary endurance The investigators will test 2 modes of delivery, one using the printed exercise manual and the other using Pt PAL, a mobile health technology application. Pt PAL can facilitate communication between the care team and patients, and allows the team to send from their web-portal, exercise routines, surveys and educational material to the patient's mobile device. The Pt PAL app then captures the patient activity adherence, and reports those results back to the team including a graphical summary about patients' condition and activity. The investigators have successfully applied Pt PAL exercise program to other patient populations (e.g., heart failure patients) in Montefiore Medical Center, and the app has received regulatory approval at Montefiore.
The research team composed of Rehabilitation Medicine physician, Internal Medicine specialist, rehabilitation therapists, nursing, medical students and research staff are very well positioned to carry out a study of this nature effectively and safely to its conclusion.
The investigators will assess the changes in the following measures
- Activity Measure for Post-Acute Care (AM-PAC)12 which was developed to examine basic mobility and daily activity functional activities important to adults.
- St George's Respiratory function questionnaire to assess pulmonary function. It is scored for symptoms, physical activity, and impact domains
- Short Physical Performance Battery (SPPB ) is a series of physical performance tests used in older persons to assess lower extremity function, balance and mobility and is predictive of a broad range of adverse outcomes, including mortality, incident disability, falls, hospitalization and healthcare utilization.
- The Picture Memory Impairment Screen is a brief, 4-item free and cued recall test of memory that uses pictures to overcome many of the educational, cultural, and logistical barriers to cognitive screening in clinical settings and is nondiscriminatory with regard to culture and literacy.
- The Paper Match Stimuli, a rapid paper test that can be administered under 3 minutes correlate predominantly with brain regions mediating information processing speed (i.e., basal ganglia) and executive functions (i.e., dorsolateral prefrontal and parietal cortex
- The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, which can help identify patients whose motivation for exercise may be impacted by depression
- Conditions
- Corona Virus Infection
- Being tested
- PT Pal, Exercise Manual
- Keywords
- coronavirus, covid, covid-19, covid19, corona
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT PalOther
Patients will be guided through individualized exercises that will be selected by their primary physical therapists. The exercises aim to improve lung function, maintain joint flexibility, muscle strength balance and mobility
Exercise ManualOther
Patients will be guided through individualized exercises that will be selected by their primary physical therapists. The exercises aim to improve lung function, maintain joint flexibility, muscle strength, balance and mobility
| Study group | Role | What they receive |
|---|---|---|
| PT Pal | Experimental | Experimental Arm-PT PAL Participants randomized into this arm will receive exercise instructions via Pt_PAL. PT PAL is a mobile health technology used to facilitate communications between Care teams and patients, by allowing the team to send web-based exercise routines, surveys and educational materials. The PT Pal app captures patient activity adherence and reports Receives: Other: PT Pal |
| Exercise Manual | Active comparator | Control Arm- Exercise Manual Participants randomized into this arm will use the exercise manual to obtain their exercise instructions Receives: Other: Exercise Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence: Number of Days patient exercises independently at least 1 time a day
Measured: 1 year
Recruitment , Implementation and Retention: number of patients contacted, enrolled and completed study
Measured: 1 year
Safety: Number of adverse health events
Measured: 1 year
Secondary outcomes (7)
Activity Measure for Post-Acute Care (AM-PAC).
The range is 6-24; higher scores reflect better mobility
Measured: 1 year
St George's Respiratory function questionnaire
The range is 0 to 100; higher scores worse.
Measured: 1 year
Short Physical Performance Battery (SPPB )
The scores range from 0-12, higher scores reflect better lower extremity function.
Measured: 1 year
The Picture Memory Impairment Screen
The scores range from 0-8, higher scores reflect better memory function.
Measured: 1 year
The Paper Match Stimuli.
The scores range from 0-52, higher scores better processing speed and executive function.
Measured: 1 year
The Beck Depression Inventory (BDI).
The scores range from 0-63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Measured: 1 year
Discharge Destination
Percentage of patients being discharged home, versus those who require discharge to rehabilitation hospitals
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study startNov 2021 (estimated)
- Primary completion23 Feb 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: COVID patients admitted to the hospital during the study dates did NOT have the criteria to enter the study(i.e they were too medically unstable) or their hospital stay was too short to conduct a before and after assessment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Felice Ambrose, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821531
- Sponsor's protocol ID
- 2020-12575
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding a Self-guided Exercise Program on Functional Outcomes Among Hospitalized COVID-19 Patients: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04821531
- Acronym / sponsor ID
- 2020-12575
- Conditions
- Corona Virus Infection
- Keywords
- coronavirus, covid, covid-19, covid19, corona
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID patients admitted to the hospital during the study dates did NOT have the criteria to enter the study(i.e they were too medically unstable) or their hospital stay was too short to conduct a before and after assessment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- 23 Feb 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Mar 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.
The investigators' aim is to conduct a study looking into safety and feasibility study of Covid patients participating in a self-guided exercises program while admitted to the hospital. The investigators will test 2 forms of exercise instruction, one using an exercise phone-based application, and the other a printed exercise manual.
Detailed description
The COVID-19 pandemic has resulted in significant morbidity and mortality throughout the world. As of March 16, 2021 there were over 119 million confirmed COVID-19 cases and 2.6 million deaths globally. The majority of COVID-19 cases are mild to moderate, resulting in symptom resolution within 6 weeks of symptom onset.
Following moderate to severe COVID-19 infections, functional impairments are likely to be dominated by peripheral muscle dysfunction (due to deconditioning and decreased lean body mass, ICU neuropathy, fatigue and the effects of hypoxemia), respiratory muscle dysfunction (dysfunctional breathing pattern, DBP, and exercise-induced laryngeal obstruction), cardiac impairment and deconditioning, and psychosocial factors (anxiety, depression, guilt, sleep disturbance and dependency).
Physical exercise has proven to be an effective therapy for most chronic diseases and microbial infections with preventive or therapeutic benefits involving the primary immunological mediators and/or anti-inflammatory properties. Another mechanism is that it can counteract the effect of prolonged bedrest by preventing the decline in muscle strength, muscle mass loss , reduce exaggerated cardiac response to exercise, reduce thromboembolism, and improve lung function. Prior research in COPD patients have shown that early pulmonary rehabilitation showed reductions in mortality, length of stay and readmission.
There has been some concern among physicians about allowing patients with COVID-19 to exercise. This is also of concern to all practitioners of Rehabilitation Medicine and the investigators seek to understand the risks better. This research group is currently concluding another retrospective study of 988 COVID-19 patients that suggest that not only is exercise safe, but increasing the number of exercise interventions improves the functional status of the patients and may reduce mortality.
As the next step, the investigators propose a 12-month, single blind feasibility study to determine if adding a self-guided exercise to a patient population already receiving two 30-minutes/week therapy can improve the patient's overall functional and cognitive outcomes. The overall hypothesis is that COVID-19 patients admitted to the hospital with mild to moderate disease can safely perform these exercises and improve their physical and cognitive functioning. The objective in performing this study is to examine feasibility as well as obtain preliminary data to design future RCT studies in this or other similar diseases. The self-guided exercise program was developed by the Department of Rehabilitation at Montefiore during the initial COVID-19 surge. The manual has been published in the Journal for the International Society of Physical and Rehabilitation Medicine and has been distributed through many medical society websites. COVID-19 patients admitted to the Montefiore Hospital have been receiving the exercise manual upon discharge for the past 9 months. The exercises in the program are divided into 3 levels. The initial level focuses on prevention of lung complication associated with COVID-19, and prevention of contracture in the large joints associated with bedrest. The next level focuses on improving sitting tolerance, strengthening limb and accessory muscles of breathing. The final level works on standing balance, large muscle strengthening, and building cardiopulmonary endurance The investigators will test 2 modes of delivery, one using the printed exercise manual and the other using Pt PAL, a mobile health technology application. Pt PAL can facilitate communication between the care team and patients, and allows the team to send from their web-portal, exercise routines, surveys and educational material to the patient's mobile device. The Pt PAL app then captures the patient activity adherence, and reports those results back to the team including a graphical summary about patients' condition and activity. The investigators have successfully applied Pt PAL exercise program to other patient populations (e.g., heart failure patients) in Montefiore Medical Center, and the app has received regulatory approval at Montefiore.
The research team composed of Rehabilitation Medicine physician, Internal Medicine specialist, rehabilitation therapists, nursing, medical students and research staff are very well positioned to carry out a study of this nature effectively and safely to its conclusion.
The investigators will assess the changes in the following measures
- Activity Measure for Post-Acute Care (AM-PAC)12 which was developed to examine basic mobility and daily activity functional activities important to adults.
- St George's Respiratory function questionnaire to assess pulmonary function. It is scored for symptoms, physical activity, and impact domains
- Short Physical Performance Battery (SPPB ) is a series of physical performance tests used in older persons to assess lower extremity function, balance and mobility and is predictive of a broad range of adverse outcomes, including mortality, incident disability, falls, hospitalization and healthcare utilization.
- The Picture Memory Impairment Screen is a brief, 4-item free and cued recall test of memory that uses pictures to overcome many of the educational, cultural, and logistical barriers to cognitive screening in clinical settings and is nondiscriminatory with regard to culture and literacy.
- The Paper Match Stimuli, a rapid paper test that can be administered under 3 minutes correlate predominantly with brain regions mediating information processing speed (i.e., basal ganglia) and executive functions (i.e., dorsolateral prefrontal and parietal cortex
- The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, which can help identify patients whose motivation for exercise may be impacted by depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT Pal | Experimental | Other: PT PalExperimental Arm-PT PAL Participants randomized into this arm will receive exercise instructions via Pt_PAL. PT PAL is a mobile health technology used to facilitate communications between Care teams and patients, by allowing the team to send web-based exercise routines, surveys and educational materials. The PT Pal app captures patient activity adherence and reports |
| Exercise Manual | Active comparator | Other: Exercise ManualControl Arm- Exercise Manual Participants randomized into this arm will use the exercise manual to obtain their exercise instructions |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COVID-19 Positive by PCR testing
- Adults aged 50-75
- Patients evaluated by Rehabilitation team and found appropriate for the study
- Able to read and understand English or Spanish
- Have access to a smartphone
Key exclusion criteria (5 listed)
- Pregnant patients
- Patients with dementia or cognitive dysfunction
- Patients who exhibit poor safety or unsafe behavior
- Patients who need high flow oxygen, rebreather or any form of ventilatory support
- Patients with chest tubes or similar attachments
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 |
|---|---|---|
| PT PalPatients will be guided through individualized exercises that will be selected by their primary physical therapists. The exercises aim to improve lung function, maintain joint flexibility, muscle strength balance and mobility | Other | PT Pal |
| Exercise ManualPatients will be guided through individualized exercises that will be selected by their primary physical therapists. The exercises aim to improve lung function, maintain joint flexibility, muscle strength, balance and mobility | Other | Exercise Manual |
Primary outcome
Adherence: Number of Days patient exercises independently at least 1 time a day
Time frame: 1 year
Recruitment , Implementation and Retention: number of patients contacted, enrolled and completed study
Time frame: 1 year
Safety: Number of adverse health events
Time frame: 1 year
7 secondary outcomes
Activity Measure for Post-Acute Care (AM-PAC).
Time frame: 1 year
St George's Respiratory function questionnaire
Time frame: 1 year
Short Physical Performance Battery (SPPB )
Time frame: 1 year
The Picture Memory Impairment Screen
Time frame: 1 year
The Paper Match Stimuli.
Time frame: 1 year
The Beck Depression Inventory (BDI).
Time frame: 1 year
Discharge Destination
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- 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.
Anne Felice Ambrose, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PT Pal and Exercise Manual in people with Corona Virus Infection, run by Montefiore Medical Center 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 1 Apr 2022. 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 withdrawn before enrolling participants, so there are no results.
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?
Adherence: Number of Days patient exercises independently at least 1 time a day (time frame: 1 year). The study lists 3 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 1 Apr 2022.