NCT04647682

Brief Summary

Our hypothesis was that physical activity program will be acceptable and may counteract physical and mental decline among older adults hospitalized in COVID-19 unit

Trial Health

90
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
2 countries

3 active sites

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

First Submitted

Initial submission to the registry

October 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

October 29, 2020

Last Update Submit

May 31, 2023

Conditions

Keywords

older adultshospitalphysical activity program

Outcome Measures

Primary Outcomes (1)

  • Change of adherence of the intervention

    adherence of the intervention evaluated by the number of completed exercise days compared to the number of total intervention days

    through study completion, an average of 15 days

Secondary Outcomes (1)

  • Change of physical performances

    through study completion, an average of 15 days

Study Arms (1)

One single group study

Patients aged 75 years and over Hospitalized in a French COVID-19 geriatric unit Positive COVID-19 infection made by Real-time Polymerase Chain Reaction COVID-19 or suspected on thoracic lesions on computerized tomography.

Other: physical activity program

Interventions

* 30 second chair test, * balance with joint-feet and semi-tandem stance * 4 meters comfortable walking test were evaluated

One single group study

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Included in a French COVID-19 geriatric unit in Toulouse, hospitalized for a positive COVID-19 infection

You may qualify if:

  • Patients aged 75 years and over
  • Hospitalized in a French COVID-19 geriatric unit
  • Positive COVID-19 infection made by Real-time Polymerase Chain Reaction COVID-19 or suspected on thoracic lesions on computerized tomography.

You may not qualify if:

  • Severe dementia or Mini Mental State Examination (MMSE) \[14\] below 18/30
  • Acute COVID-19 complication.
  • Activities of Daily Living \< 2/6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Grenoble

Grenoble, France

Location

University Hospital Toulouse

Toulouse, 31059, France

Location

CHU Pointe-à-Pitre Abîmes - GUADELOUPE

Pointe-à-Pitre, Guadeloupe

Location

Related Publications (1)

  • Andre L, Rolland Y, Gerard S, Kergoat MJ, Peyrusque E, Aubertin-Leheudre M. Feasibility and Effect of Implementing Physical Activity Program Implementation during Covid-19 in Hospitalized Positive Covid-19 Older Adults. J Nutr Health Aging. 2021;25(6):724-726. doi: 10.1007/s12603-021-1596-4. No abstract available.

    PMID: 34179924BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yves ROLLAND, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

December 1, 2020

Study Start

January 5, 2021

Primary Completion

February 14, 2022

Study Completion

February 14, 2022

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations