NCT05395390

Brief Summary

This study is being done to understand body's response to hybrid home-based and on-site rehabilitation program utilizing individually tailored exercises throughout a total of 18 sessions with 12 of them occurring onsite, in people with and without chronic respiratory diseases, such as Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) and in individuals recovered from COVID-19. Exercise training programs vary widely for people with COPD, OSA, and during prolonged recovery from COVID infection. This study will help identify if this program is helpful to address muscle loss and fatigue specifically in populations with and without chronic respiratory diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

December 10, 2021

Last Update Submit

September 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Whole-body protein and amino acid metabolism response to training

    Whole-body production rate measured after stable tracer administration

    up to 8 weeks Exercise Intervention

Secondary Outcomes (21)

  • Body Composition using Dual Energy X-Ray Absorptiometry bone density

    up to 8 week Exercise Intervention

  • Body Composition using Dual Energy X-Ray Absorptiometry Muscle

    up to 8 week Exercise Intervention

  • Body Composition using Dual Energy X-Ray Absorptiometry Fat

    up to 8 week Exercise Intervention

  • Bone mineral density by BIA

    up to 8 week Exercise Intervention

  • Handgrip strength dynamometry by Handgrip Dynamometer

    up to 8 week Exercise Intervention

  • +16 more secondary outcomes

Interventions

Resistance Training done both at home and on site using either dumbells or keiser pneumatic exercise machines respectively

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to walk, sit down and stand up independently
  • Age 30 - 85 years
  • Ability to lay in supine or elevated position for up to 3 hours
  • Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 \< 70% of reference FEV1
  • or- Obstructive Sleep Apnea (OSA)
  • or- 2 weeks post-recovered\* from laboratory confirmed case of COVID
  • ● Willingness and ability to comply with the protocol
  • \*Recovered is defined according to Brazos County Health District as someone who has been fever-free for 24 hours without fever-reducing medications, and it has been 10 days after onset of symptoms.
  • Healthy male or female according to the investigator's or appointed staff's judgment
  • Ability to walk, sit down and stand up independently
  • Age 30 - 85 years
  • Ability to lay in supine or elevated position for up to 3 hours
  • No diagnosis of chronic lung disease
  • Willingness and ability to comply with the protocol

You may not qualify if:

  • Unable to exercise due to physical limitations (i.e. neuromuscular and/or orthopedic disorders)
  • Established diagnosis of malignancy
  • Presence of acute illness or metabolically unstable chronic illness
  • Presence of fever within the last 3 days.
  • Expected to have surgery within 1 month of screening or during exercise training
  • Any other condition according to the PI or research staff that was found during the screening visit, that would interfere with the study or safety of the patient.
  • Previous injury that could interfere with participation in resistance exercise protocol.
  • Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
  • (Possible) pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

Related Publications (1)

  • Yu AK, Deutz NEP, Perez CN, DeWandel S, Ruebush LE, Engelen MPKJ. The acute effects of alpha-lactalbumin intake on tryptophan metabolites and mood in older adults with Mild Cognitive Impairment. Nutr Neurosci. 2025 Sep 14:1-15. doi: 10.1080/1028415X.2025.2554359. Online ahead of print.

MeSH Terms

Conditions

COVID-19Pulmonary Disease, Chronic Obstructive

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2021

First Posted

May 27, 2022

Study Start

February 2, 2021

Primary Completion

August 7, 2023

Study Completion

August 7, 2023

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations