NCT04796064

Brief Summary

Sarcopenia is the major health concern and common consequence of COVID-19 in the ageing population. The objective of this study is to find and compare low and high-intensity aerobic training protocols on clinical and psychological effects in community-dwelling older men with post-COVID 19 Sarcopenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 10, 2021

Last Update Submit

March 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Handgrip strength

    It is a simple and cost-effective test to measure the upper limb strength

    8 weeks

Study Arms (2)

low-intensity aerobic training group

EXPERIMENTAL
Other: low-intensity aerobic training

high-intensity aerobic training group

EXPERIMENTAL
Other: low-intensity aerobic training

Interventions

A low-intensity aerobic training group started with 15 minutes of warm-up, which includes static stretching of the upper and lower limb muscles. then participants were instructed to do 30 minutes of low-intensity aerobic training exercises, which include 20 minutes on the treadmill and 10 minutes of cycle ergometer, followed by 10 minutes of cool down. \- In high-intensity training (HAT) the same protocol has been followed, but the intensity of exercises was fixed between 60% to 80 % of maximum heart rate. The strength training includes major group muscles such as shoulder flexors, extensors, and abductors, elbow flexors and extensors, hip flexors\& extensors, knee flexors\&extensors, abdominal and back muscles also were trained. Each group of muscles was trained for 10 repetitions for 3 sets with a rest period of 5 minutes.

high-intensity aerobic training grouplow-intensity aerobic training group

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range of 60 - 80 years with
  • A positive diagnosis of post-COVID-19 sarcopenia

You may not qualify if:

  • Under medication
  • History of lower limb surgeries, fractures
  • Cardiac problems
  • Respiratory problems
  • Neurological problems
  • Systemic problems and any other contraindications for aerobic training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 12, 2021

Study Start

March 30, 2020

Primary Completion

November 5, 2020

Study Completion

December 15, 2020

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations