AzTrials
AzTrials

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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.

United States1 site
  • Montefiore Medical Center

    New York, New York, 10467

Other trials in United States

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

  1. Activity Measure for Post-Acute Care (AM-PAC)12 which was developed to examine basic mobility and daily activity functional activities important to adults.
  2. St George's Respiratory function questionnaire to assess pulmonary function. It is scored for symptoms, physical activity, and impact domains
  3. 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.
  4. 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.
  5. 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
  6. 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
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 groups in NCT04821531
Study groupRoleWhat they receive
PT PalExperimentalExperimental 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 ManualActive comparatorControl 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.

  1. Adherence: Number of Days patient exercises independently at least 1 time a day

    Measured: 1 year

  2. Recruitment , Implementation and Retention: number of patients contacted, enrolled and completed study

    Measured: 1 year

  3. Safety: Number of adverse health events

    Measured: 1 year

Secondary outcomes (7)
  1. Activity Measure for Post-Acute Care (AM-PAC).

    The range is 6-24; higher scores reflect better mobility

    Measured: 1 year

  2. St George's Respiratory function questionnaire

    The range is 0 to 100; higher scores worse.

    Measured: 1 year

  3. Short Physical Performance Battery (SPPB )

    The scores range from 0-12, higher scores reflect better lower extremity function.

    Measured: 1 year

  4. The Picture Memory Impairment Screen

    The scores range from 0-8, higher scores reflect better memory function.

    Measured: 1 year

  5. The Paper Match Stimuli.

    The scores range from 0-52, higher scores better processing speed and executive function.

    Measured: 1 year

  6. 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

  7. 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.

  1. First posted29 Mar 2021
  2. Study startNov 2021 (estimated)
  3. Primary completion23 Feb 2022 (estimated)
  4. 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

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in