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

NCT ID: NCT05934279

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Resistance Training

Training aimed at improving balance and strengthening muscle strength (RT) will be held twice a week, 45 min per session for 8 weeks

Group Type EXPERIMENTAL

Resistance Training

Intervention Type DEVICE

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

Control Group

Group without training program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Józef Piłsudski University of Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AWF Warszawa

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Katarzyna Kaczmarczyk, Habilitated Doctor

Role: CONTACT

22 834 04 31

Mateusz Baran, PhD student

Role: CONTACT

500220003

Facility Contacts

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Malgorzata Butkieiwcz-Ostrowska, mgr

Role: primary

228641418

Other Identifiers

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SKE 01-41/2022

Identifier Type: -

Identifier Source: org_study_id

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