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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+

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
Józef Piłsudski University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring post-COVID-19, elderly individuals, balance disorder

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • AWF WarszawaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance Training

Control Group

Arm Description

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

Group without training program

Outcomes

Primary Outcome Measures

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.
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.
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).
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.
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).
Balance assessment fourth
OSI (overall stability index)
Balance assessment fifth
APSI (anterior-posterior stability index)
Balance assessment sixth
MLSI (medial-lateral stability index).
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.
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
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

Secondary Outcome Measures

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.

Full Information

First Posted
January 3, 2023
Last Updated
June 28, 2023
Sponsor
Józef Piłsudski University of Physical Education
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1. Study Identification

Unique Protocol Identification Number
NCT05934279
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Józef Piłsudski University of Physical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
post-COVID-19, elderly individuals, balance disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance Training
Arm Type
Experimental
Arm Description
Training aimed at improving balance and strengthening muscle strength (RT) will be held twice a week, 45 min per session for 8 weeks
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Group without training program
Intervention Type
Device
Intervention Name(s)
Resistance Training
Intervention Description
All training exercise involve balance and strength improvement. Consist of 8 weeks of trainings per 2 trainings in each week, ongoing 45 minutes.
Primary Outcome Measure Information:
Title
Muscle strength under dynamic conditions first
Description
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.
Time Frame
Day 1
Title
Muscle strength under dynamic conditions second
Description
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.
Time Frame
Day 1
Title
Balance assessment first
Description
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).
Time Frame
Day 1
Title
Balance assessment second
Description
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.
Time Frame
Day 1
Title
Balance assessment third
Description
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).
Time Frame
Day 1
Title
Balance assessment fourth
Description
OSI (overall stability index)
Time Frame
Day 1
Title
Balance assessment fifth
Description
APSI (anterior-posterior stability index)
Time Frame
Day 1
Title
Balance assessment sixth
Description
MLSI (medial-lateral stability index).
Time Frame
Day 1
Title
Body Composition BMI (kg/m^2) measured by DXA (dual-energy X-ray absorptiometry)
Description
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.
Time Frame
Day 1
Title
Body Height BSM170 (InBody, 'Biospace Company', Japan)
Description
During each series of testing, body height will be measured to the nearest 0.1 cm with digital stationmaster
Time Frame
Day 1
Title
Body Mass (InBody 720, 'Biospace Company', Japan)
Description
During each series of testing, body mass will be determined to the nearest 0.1 kg with a medical scale
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Quality of life tests World Health Organization Quality of Life Scale(WHOQOL-Bref)
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Kaczmarczyk, Habilitated Doctor
Phone
22 834 04 31
Email
katarzyna.kaczmarczyk@awf.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Mateusz Baran, PhD student
Phone
500220003
Email
mb683@stud.awf.edu.pl
Facility Information:
Facility Name
AWF Warszawa
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata Butkieiwcz-Ostrowska, mgr
Phone
228641418
Email
malgorzata.ostrowska@awf.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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