- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821531
Feasibility of a Self-guided Exercise Program Among Hospitalized COVID-19 Patients
Impact of Adding a Self-guided Exercise Program on Functional Outcomes Among Hospitalized COVID-19 Patients: A Randomized Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10467
- Montefiore Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion
- 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
Exclusion
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PT Pal
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
|
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
|
Active Comparator: Exercise Manual
Control Arm- Exercise Manual Participants randomized into this arm will use the exercise manual to obtain their exercise instructions
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adherence: Number of Days patient exercises independently at least 1 time a day
Time Frame: 1 year
|
1 year
|
Recruitment , Implementation and Retention: number of patients contacted, enrolled and completed study
Time Frame: 1 year
|
1 year
|
Safety: Number of adverse health events
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity Measure for Post-Acute Care (AM-PAC).
Time Frame: 1 year
|
The range is 6-24; higher scores reflect better mobility
|
1 year
|
St George's Respiratory function questionnaire
Time Frame: 1 year
|
The range is 0 to 100; higher scores worse.
|
1 year
|
Short Physical Performance Battery (SPPB )
Time Frame: 1 year
|
The scores range from 0-12, higher scores reflect better lower extremity function.
|
1 year
|
The Picture Memory Impairment Screen
Time Frame: 1 year
|
The scores range from 0-8, higher scores reflect better memory function.
|
1 year
|
The Paper Match Stimuli.
Time Frame: 1 year
|
The scores range from 0-52, higher scores better processing speed and executive function.
|
1 year
|
The Beck Depression Inventory (BDI).
Time Frame: 1 year
|
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.
|
1 year
|
Discharge Destination
Time Frame: 1 year
|
Percentage of patients being discharged home, versus those who require discharge to rehabilitation hospitals
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Felice Ambrose, MD, Montefiore Medical Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-12575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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