Feasibility of a Self-guided Exercise Program Among Hospitalized COVID-19 Patients

Sponsor
Montefiore Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04821531
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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. The investigators will test 2 forms of exercise instruction, one using an exercise phone-based application, and the other a printed exercise manual.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: PT Pal
  • Other: Exercise Manual
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Single blind(outcome assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Adding a Self-guided Exercise Program on Functional Outcomes Among Hospitalized COVID-19 Patients: A Randomized Prospective Study
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Feb 23, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/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

Other: PT Pal
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

Other: Exercise Manual
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

Outcome Measures

Primary Outcome Measures

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

  2. Recruitment , Implementation and Retention: number of patients contacted, enrolled and completed study [1 year]

  3. Safety: Number of adverse health events [1 year]

Secondary Outcome Measures

  1. Activity Measure for Post-Acute Care (AM-PAC). [1 year]

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

  2. St George's Respiratory function questionnaire [1 year]

    The range is 0 to 100; higher scores worse.

  3. Short Physical Performance Battery (SPPB ) [1 year]

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

  4. The Picture Memory Impairment Screen [1 year]

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

  5. The Paper Match Stimuli. [1 year]

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

  6. The Beck Depression Inventory (BDI). [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.

  7. Discharge Destination [1 year]

    Percentage of patients being discharged home, versus those who require discharge to rehabilitation hospitals

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Montefiore Medical CenterNew YorkNew YorkUnited States10467

Sponsors and Collaborators

  • Montefiore Medical Center

Investigators

  • Principal Investigator: Anne Felice Ambrose, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT04821531
Other Study ID Numbers:
  • 2020-12575
First Posted:
Mar 29, 2021
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Montefiore Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022