Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms

NCT04958161 | Withdrawn

• 1 other identifier: IRB00075690
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals who had COVID-19 and are thought to have recovered from the disease often experience long-term symptoms such as fatigue, extreme tiredness and shortness of breath, a condition referred to as Long COVID. Previous studies have shown that regular exercise is beneficial for individuals suffering similar symptoms as a result of other diseases such as Chronic Fatigue Syndrome. The goal of this study is determine if participation in a three-month structured exercise program will improve physical function in individuals suffering from Long COVID.

Conditions

Covid19

Keywords

exercise; rehabilitation; physical function

Outcome Measures

Primary Outcomes (4)

• Performance Based Physical Function

  Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded.

  Baseline

• Performance Based Physical Function

  Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded.

  Week 12

• Self-reported Physical Function

  The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10.

  Baseline

• Self-reported Physical Function

  The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10.

  Week 12

Secondary Outcomes (1)

• Physical Function

  Baseline and Week 12

Other Outcomes (11)

• Lung Volumes and Capacities

  Baseline and Week 12

• Air Flow

  Baseline and Week 12

• Diffusion Capacity

  Baseline and Week 12

Study Arms (2)

Exercise Therapy

EXPERIMENTAL

Exercise therapy will be performed three times per week for 12 weeks.

Other: Exercise Therapy

Wait List Control

NO INTERVENTION

Wait-list-control participants will be asked to continue their normal activities over the 12 week period.

Interventions

Exercise Therapy OTHER

Each exercise session will involve 5 to10 minutes of stretching and slow walking followed by a 30 minute stimulus phase of aerobic exercise. Exercise intensity during the stimulus phase will be prescribed based on the graded exercise test results and will be gradually increased with the goal of the participant exercising continuously for 30 minutes at 50% to 85% of symptom-limited maximum heart rate, or maintained at a level below that which causes symptomatic or silent ischemia. Following the aerobic phase of exercise, participants will complete one set of 8 to 12 repetitions of muscle-strengthening activities for all major muscle groups (legs, hips, back, abdomen, chest, shoulders, and arms). Participants will be provided with a home based aerobic exercise program. They will be encouraged to perform this home-based program twice a week on days when they are not attending the center-based program.

Exercise Therapy

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to read and speak English
• Proof of a positive nucleic acid amplification test for the determination of COVID-19
• Two months post positive nucleic acid amplification test for the determination of COVID
• Self-report of COVID-19 symptoms (symptoms include any of the following: reduced exercise capacity, fatigue, cough, shortness of breath, headache and/or joint pain)
• Able to understand and willing to sign a written informed consent document
• Willing and able to complete all study procedures including attending all exercise sessions

You may not qualify if:

• Currently exercising more than 60 minutes per week at a moderate intensity or 30 minutes per week at a high intensity
• Current use of supplemental oxygen
• Active treatment for cancer
• Severe congestive heart failure, pulmonary disease, stroke, peripheral vascular disease, coronary artery disease and/or valvular heart disease
• Positive graded exercise test
• Major psychiatric disease
• Severe liver or hepatic disease
• Uncontrolled hypertension or diabetes
• Orthopedic impairment that prevents participation in an exercise program
• Blindness
• BMI \> 40kg/m2
• Living more than 35 miles from exercise facility
• Plans to move within the next 6 months

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

MeSH Terms

Conditions

COVID-19; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Michael J Berry, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 12, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: February 24, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after publication
• Access Criteria: IPD that underlie results in a publication will be posted to a publicly accessible website following publication.

Locations

US (1)