Clinical trial NCT05934279: Developing an Effective Intervention to Address Post-Corona-Virus-Disease-2019 Balance Disorders, Weakness and Muscle Fatigue in Individuals Aged 65+
Official title: Developing an Effective Intervention to Address Post-COVID-19 Balance Disorders, Weakness and Muscle Fatigue in Individuals Aged 65+
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: post-COVID-19
elderly individuals
balance disorder
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Muscle strength under dynamic conditions first
timeFrame: Day 1
measure: Muscle strength under dynamic conditions second
timeFrame: Day 1
measure: Balance assessment first
timeFrame: Day 1
measure: Balance assessment second
timeFrame: Day 1
measure: Balance assessment third
timeFrame: Day 1
measure: Balance assessment fourth
timeFrame: Day 1
measure: Balance assessment fifth
timeFrame: Day 1
measure: Balance assessment sixth
timeFrame: Day 1
measure: Body Composition BMI (kg/m^2) measured by DXA (dual-energy X-ray absorptiometry)
timeFrame: Day 1
measure: Body Height BSM170 (InBody, 'Biospace Company', Japan)
timeFrame: Day 1
measure: Body Mass (InBody 720, 'Biospace Company', Japan)
timeFrame: Day 1
Secondary outcomes:
measure: Quality of life tests World Health Organization Quality of Life Scale(WHOQOL-Bref)
timeFrame: Day 1
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: AWF Warszawa
Study officials:
References: