Developing an Effective Intervention to Address Post-Corona-Virus-Disease-2019 Balance Disorders, Weakness and Muscle Fatigue in Individuals Aged 65+

COVID-19 Clinical Trial

Official title:

Developing an Effective Intervention to Address Post-COVID-19 Balance Disorders, Weakness and Muscle Fatigue in Individuals Aged 65+

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934279
• Other study ID #: SKE 01-41/2022
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2022
• Source: Józef Pilsudski University of Physical Education
• Contact: Katarzyna Kaczmarczyk, Habilitated Doctor
• Phone: 22 834 04 31
• Email: katarzyna.kaczmarczyk[@]awf.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The long-term consequences and sequelae of COVID-19 are still unclear; however, a vast number of elderly individuals have reported prolonged general weakness and muscular fatigue, leading to significant functional decline, increased risk of falls, morbidity and mortality rates. However, effective exercise intervention for such post-COVID-19 patients is still not well documented. Previous studies indicate that, in general, resistance training (RT) appears to be the most effective, safe method for combating the loss of muscle mass, strength and functional capacity. The aim of investigators study is to develop/adopt an effective intervention specifically for elderly (65+) people with post COVID-19 condition, experiencing balance disorder and muscle weakness, in order to help them return to pre-infection mobility and function. This will be a randomized controlled study with pre- and post-intervention assessment. The participants will be recruited from nursing homes, retirement facilities, Universities of the Third Age, primary health care units (POZs), in keeping with the inclusion criteria. The patients will be randomized to one of 2 groups: RT and control (no exercise). The participants' muscle strength under dynamic condition, balance (especially fall risk), body composition and quality of life will be assessed pre- and post-intervention. The investigators main research outcome - safe exercise protocols and interventions - will be developed to match the needs of the elderly in the current pandemic (and post-pandemic) scenario, in order to maintain/improve the health, balance, muscle strength, cognitive function and, consequently, quality of life of older adults affected by COVID-19.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• positive Polymerase Chain Reaction test

• positive result in test for antibodies against the Severe Acute Respiratory Syndrome-Corona Virus -2 coronavirus 3-12 months prior to the study start

Exclusion Criteria:

• cardiac dysfunction,

• stress disorder,

• oxygen desaturation,

• dysfunction of the autonomic nervous system (orthostatic intolerance)

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Resistance Training
All training exercise involve balance and strength improvement. Consist of 8 weeks of trainings per 2 trainings in each week, ongoing 45 minutes.

Locations

Country	Name	City	State
Poland	AWF Warszawa	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength under dynamic conditions first	Muscle strength will be measured under dynamic (for the knee muscles) and static conditions (for the elbow, knee, hip and ankle muscles). Both legs and arms will be tested. Isokinetic knee strength will be examined using the Biodex System 3 Professional dynamometer (Biodex Medical Systems, New York,USA) Maximal muscle strength will be defined as the highest peak torque (Newton-meters, Nm). To allow adaptation prior to the examination, subjects will be allowed to practice the motions 3 times prior to testing. Maximal Voluntary Contraction (MVC) will be measured in sitting position using 'JBA Staniak' equipment. Ankle, knee, hip and elbow joint will be standing in 90 degrees positions and isometric contraction will be calculated.The procedure will be repeated twice and isometric contraction will be held for 3 seconds in each muscle group.	Day 1
Primary	Muscle strength under dynamic conditions second	The peak torques at angular velocities of 60°/s (5 times) and 180°/s (10 times) will be measured. To allow adaptation prior to the examination, subjects will be allowed to practice the motions 3 times prior to testing. Ankle, knee, hip and elbow joint will be standing in 90 degrees positions and isometric contraction will be calculated.The procedure will be repeated twice and isometric contraction will be held for 3 seconds in each muscle group.	Day 1
Primary	Balance assessment first	Three protocols are prepared on the Biodex Balance System Standard Definition platform from Biodex (BBS). Each of them lasts 20 seconds. The BBS enables subjects to be tested on a stable or unstable platform on 12 levels, with the degree of instability of the platform increasing from 12 to 1 (the most stable platform being level 12).	Day 1
Primary	Balance assessment second	The Fall Risk Test is also carried out with EO on an unstable platform at levels ranging from 12 to 8, and 6 to 2. On this basis, the fall risk index (FRI) will be determined.	Day 1
Primary	Balance assessment third	Postural Stability Test (PST) is performed on a stationary platform with eyes open (EO) and closed (EC) to determine: an OSI (overall stability index), APSI (anterior-posterior stability index) and MLSI (medial-lateral stability index).	Day 1
Primary	Balance assessment fourth	OSI (overall stability index)	Day 1
Primary	Balance assessment fifth	APSI (anterior-posterior stability index)	Day 1
Primary	Balance assessment sixth	MLSI (medial-lateral stability index).	Day 1
Primary	Body Composition BMI (kg/m^2) measured by DXA (dual-energy X-ray absorptiometry)	During each series of testing, body composition called BMI (kg/m^2) will be evaluated using the DXA (dual-energy X-ray absorptiometry) method (GE Lunar Prodigy, GE Healthcare, Madison, Wisconsin, USA) in all participants.	Day 1
Primary	Body Height BSM170 (InBody, 'Biospace Company', Japan)	During each series of testing, body height will be measured to the nearest 0.1 cm with digital stationmaster	Day 1
Primary	Body Mass (InBody 720, 'Biospace Company', Japan)	During each series of testing, body mass will be determined to the nearest 0.1 kg with a medical scale	Day 1
Secondary	Quality of life tests World Health Organization Quality of Life Scale(WHOQOL-Bref)	WHOQOL-Bref is a research tool used to assess quality of life in healthy and ill individuals, both for medicinal and cognitive purposes. It allows to obtain a life quality profile in the following domains: physical health, psychological health, social relationships, and environment. The scores reflect individual perceptions of life quality in these areas. Score is measured from 0 to 100 where 0 is the worst and 100 is the best result.	Day 1