Study 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
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 1, 2022
March 1, 2022
4 months
March 11, 2021
March 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adherence: Number of Days patient exercises independently at least 1 time a day
1 year
Recruitment , Implementation and Retention: number of patients contacted, enrolled and completed study
1 year
Safety: Number of adverse health events
1 year
Secondary Outcomes (7)
Activity Measure for Post-Acute Care (AM-PAC).
1 year
St George's Respiratory function questionnaire
1 year
Short Physical Performance Battery (SPPB )
1 year
The Picture Memory Impairment Screen
1 year
The Paper Match Stimuli.
1 year
- +2 more secondary outcomes
Study Arms (2)
PT Pal
EXPERIMENTALExperimental 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 COMPARATORControl Arm- Exercise Manual Participants randomized into this arm will use the exercise manual to obtain their exercise instructions
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
New York, New York, 10467, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Felice Ambrose, MD
Montefiore Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single blind(outcome assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 29, 2021
Study Start
November 1, 2021
Primary Completion
February 23, 2022
Study Completion
December 1, 2022
Last Updated
April 1, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share