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

J

Józef Piłsudski University of Physical Education

Status

Enrolling

Conditions

COVID-19

Treatments

Device: Resistance Training

Study type

Interventional

Funder types

Other

Identifiers

NCT05934279
SKE 01-41/2022

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Resistance Training
Experimental group
Description:
Training aimed at improving balance and strengthening muscle strength (RT) will be held twice a week, 45 min per session for 8 weeks
Treatment:
Device: Resistance Training
Control Group
No Intervention group
Description:
Group without training program

Trial contacts and locations

1

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Central trial contact

Mateusz Baran, PhD student; Katarzyna Kaczmarczyk, Habilitated Doctor

Data sourced from clinicaltrials.gov

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