COVID-19NCT05934279
Developing an Effective Intervention to Address Post-Corona-Virus-Disease-2019 Balance Disorders, Weakness and Muscle Fatigue in Individuals Aged 65+
A study testing Resistance Training in people with COVID-19, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Resistance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- cardiac dysfunction,
- stress disorder,
- oxygen desaturation,
- dysfunction of the autonomic nervous system (orthostatic intolerance)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
AWF Warszawa
Warsaw
Malgorzata Butkieiwcz-Ostrowska, mgr, 228641418, malgorzata.ostrowska@awf.edu.pl
About this study
Official title: Developing an Effective Intervention to Address Post-COVID-19 Balance Disorders, Weakness and Muscle Fatigue in Individuals Aged 65+
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.
- Conditions
- COVID-19
- Being tested
- Resistance Training
- Keywords
- post-COVID-19, elderly individuals, balance disorder
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingDevice
All training exercise involve balance and strength improvement. Consist of 8 weeks of trainings per 2 trainings in each week, ongoing 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training | Experimental | Training aimed at improving balance and strengthening muscle strength (RT) will be held twice a week, 45 min per session for 8 weeks Receives: Device: Resistance Training |
| Control Group | No intervention | Group without training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
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).
Measured: Day 1
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.
Measured: Day 1
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).
Measured: Day 1
Balance assessment fourth
OSI (overall stability index)
Measured: Day 1
Balance assessment fifth
APSI (anterior-posterior stability index)
Measured: Day 1
Balance assessment sixth
MLSI (medial-lateral stability index).
Measured: Day 1
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.
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Mar 2023
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934279
- Sponsor's protocol ID
- SKE 01-41/2022
- Status last verified
- Dec 2022
- First submitted
- 3 Jan 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Effective Intervention to Address Post-COVID-19 Balance Disorders, Weakness and Muscle Fatigue in Individuals Aged 65+
- ClinicalTrials.gov ID
- NCT05934279
- Acronym / sponsor ID
- SKE 01-41/2022
- Conditions
- COVID-19
- Keywords
- post-COVID-19, elderly individuals, balance disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Experimental | Device: Resistance TrainingTraining aimed at improving balance and strengthening muscle strength (RT) will be held twice a week, 45 min per session for 8 weeks |
| Control Group | No intervention | –Group without training program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- cardiac dysfunction,
- stress disorder,
- oxygen desaturation,
- dysfunction of the autonomic nervous system (orthostatic intolerance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingAll training exercise involve balance and strength improvement. Consist of 8 weeks of trainings per 2 trainings in each week, ongoing 45 minutes. | Device | Resistance Training |
Primary outcome
Muscle strength under dynamic conditions first
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
OSI (overall stability index)
Balance assessment fifth
Time frame: Day 1
APSI (anterior-posterior stability index)
Balance assessment sixth
Time frame: Day 1
MLSI (medial-lateral stability index).
Body Composition BMI (kg/m^2) measured by DXA (dual-energy X-ray absorptiometry)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
During each series of testing, body mass will be determined to the nearest 0.1 kg with a medical scale
1 secondary outcome
Quality of life tests World Health Organization Quality of Life Scale(WHOQOL-Bref)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with COVID-19, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Kaczmarczyk, Habilitated Doctor (22 834 04 31, katarzyna.kaczmarczyk@awf.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength under dynamic conditions first (time frame: Day 1). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.