FrailtyPERMANENTONCT06133894
Effect of Exercise-education Program PERMANENTO in Late Life
A study testing Exercise program PERMANENTO inspired by developmental kinesiology in people with Frailty and Sarcopenia, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The general aim of the present study is to create and empirically evaluate (RCT trial) an online education and exercise program (called PERMANENTO) to help older adults to understand the wider consequences of being active and offer them easy to follow exercise program inspired by developmental kinesiology. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Sarcopenia
- What is being tested?
- Exercise program PERMANENTO inspired by developmental kinesiology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCzechia
- Study dates
- 13 Feb 2023to 15 Jun 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- permanent residency in Prague
- being at least 70 years of age or older
- living independently at home
Who cannot join
- significant mobility limitation
- any health condition preventing from physical activity
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Centre of Expertise oi Longevity and Long-term Care
Prague, 182 00
About this study
Official title: Effect of Exercise-education Program Inspired by Developmental Kinesiology on Determinants of Sarkopenia and Frailty in Late Life
The general aim of the present study is to create and empirically evaluate (RCT trial) an online education and exercise program (called PERMANENTO) to help older adults to understand the wider consequences of being active and offer them easy to follow exercise program inspired by developmental kinesiology.
Read the detailed description
There is no doubt about the importance of a physical activity at a later age, yet it is often missing in the lives of seniors and the current epidemiological situation deepens this deficit even further. It is known that insufficient physical activity has a major effect on the decline of functional fitness components, premature development of sarcopenia or frailty syndrome, threatening self-sufficiency, health and consequently quality of life. This is associated with an increased burden on the health care system and related social services, with implications for public budgets. The aim of this project is to eliminate the onset or premature manifestation of negative aspects of aging by prevention. The content is to research a unique intervention inspired by the principles of developmental kinesiology with a presumed positive effect on the health status and the development of a comprehensive exercise and educational program for older adults. The main planned result of the project is a methodological manual and a web application containing education and exercise program for both older adults as well healthcare professionals.
The project responds to the priorities of the Applied Health Research Program for the years 2020-2026 and its focus contributes to a long-term solution of the population aging issue. With regard to demographic change, health and social care systems will be unsustainable without the adoption of preventive measures by seniors themselves. Exercise-educational intervention can lead to lasting changes and can help seniors to actively and responsibly participate in the course of their own aging. Main objective: to reduce negative health related aspects of aging, resp. their premature manifestation, by a preventive exercise-educational program. Sub-objectives: - to develop a specifically targeted exercise-educational program; - to demonstrate effectiveness of the program on health and social related indicators; - to assess acceptability, sustainability and other personal contexts - to create a methodological manual and a web platform for home-dwelling as well as institutionalized older adults containing complex information for independent exercise (how, as well as why).
- Conditions
- Frailty, Sarcopenia
- Being tested
- Exercise program PERMANENTO inspired by developmental kinesiology
- Keywords
- prevention, older adults, functional status, frailty, sarcopenia, exercise, on-line program, sustainability
- Medical subject headings
- Frailty, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program PERMANENTO inspired by developmental kinesiologyBehavioural
The intervention is based on activation of reflexive movement patterns which ensures the original reflexive control of strength, mobility and stability. After birth, we cannot control our body movements - they are reflexes "hard-wired" into our brains and vitally important for proper development of our body (muscular system, vestibular system, sensory system, cardiovascular system or digestive system) as well as our brain and nervous systems. During early childhood, everything becomes integrated and works perfectly according to the original design. But this design is slowly abandoned due to for example sedentary lifestyle and replaced by compensatory movement patterns that are making us weaker and defective with all the consequences that are becoming more severe as we age. The aim is restore the original design and improve posture and other crucial components of functional fitness and move better and more.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group was educated and instructed and agaged in a 12-week exercise program - 15 minutes 6 times per week of complex daily routines delivered via on-line platform. Receives: Behavioral: Exercise program PERMANENTO inspired by developmental kinesiology |
| Contol group | No intervention | The control group continued in regular daily activities and was offered the same intervention as the experimental group after the research trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up-and go test
Performance-based measure of functional mobility and balance in older adults.The test requires the participant to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair. The test's score is the time it takes the subject takes to complete the test. Lower score is better result.
Measured: Within a week prior the intervention and within a week after the intervention
Limits of stability on NeuroCom
The Limits of Stability (LOS) test quantifies the maximum distance participant can lean own body (i.e. intentionally weight shift) in a given direction without losing balance, stepping, or reaching for assistance as would be required for function and gait. The scores for each parameter and movement direction are represented by a numeric value. Higher score is better result.
Measured: Within a week prior the intervention and within a week after the intervention
The Sensory Organization Test on NeuroCom
The Sensory Organization Test (SOT) objectively identifies abnormalities in the patient's use of the three sensory systems that contribute to postural control: somatosensory, visual, and vestibular. The scores summarize the overall function of the three systems and the ability to resolve conflicting sensory inputs. Scores range from 0 to 100 (higher score, better result). Composite score identifies the presence of a balance control problem. Scores range from 0 to 100 (higher score, better result).
Measured: Within a week prior the intervention and within a week after the intervention
Body composition on InBody 720
The multifrequency body composition analyser InBody720 analyses body composition via the method of bioelectrical impedance (DSM-BIA) for every part of the body using 6 different frequencies (1kHz, 5kHz, 50kHz, 250kHz, 500kHz, 1000kHz) in each one of the five parts of the body with the quadrupole 8-point tactile system. It provides wide range of outcomes (main focus on: Body fat mass - lower score, better result, Skeletal muscle mass - higher score, better result, Visceral Fat - lower score, better result).
Measured: Within a week prior the intervention and within a week after the intervention
Handgrip strength on dynanometr
Handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. Participant is instructed to squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. Higher score, better result.
Measured: Within a week prior the intervention and within a week after the intervention
Perceived functional fitness and health status
Measured by questions "In general, would you say your health is poor, fair, good, very good, or excellent?" and "In general, would you say your functional fitness is poor, fair, good, very good, or excellent?". Score are represented on 5-point scale: (1) Excellent, 2) Very Good, 3) Good, 4) Fair, or 5) Poor). Lower score, better result.
Measured: Within a week prior the intervention and within a week after the intervention
Secondary outcomes (1)
Long-term sustainability
To evaluate acceptance and long-term sustainability of the program via on-line questionnaire distributed among participants. The questionnaire is rather qualitative and includes Yes vs. No answers and open ended item.
Measured: 6 and 12 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start13 Feb 2023
- Primary completion15 May 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial of volunteers over 70 years of age
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimíra Dostálová, Charles University, Czech Republic
- Investigators
- Katerina Machacova, Principal investigator, Centre of Expertise in Longevity and Long-term care, Faculty of Humanities, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133894
- Sponsor's protocol ID
- NU22-09-00447
- Acronym
- PERMANENTO
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Machacova K, Steffl M, Bartova A, Novotna B, Holmerova I. Feasibility, Acceptability, and Preliminary Effects of the Online Exercise Program PERMANENTO in Older Adults: A Randomized Controlled Trial. J Aging Phys Act. 2026 May 29:1-9. doi: 10.1123/japa.2025-0180. Online ahead of print.
PubMed 42219155
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise-education Program Inspired by Developmental Kinesiology on Determinants of Sarkopenia and Frailty in Late Life
- ClinicalTrials.gov ID
- NCT06133894
- Acronym / sponsor ID
- PERMANENTO / NU22-09-00447
- Conditions
- Frailty, Sarcopenia
- Keywords
- prevention, older adults, functional status, frailty, sarcopenia, exercise, on-line program, sustainability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 18 Nov 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 general aim of the present study is to create and empirically evaluate (RCT trial) an online education and exercise program (called PERMANENTO) to help older adults to understand the wider consequences of being active and offer them easy to follow exercise program inspired by developmental kinesiology.
Detailed description
There is no doubt about the importance of a physical activity at a later age, yet it is often missing in the lives of seniors and the current epidemiological situation deepens this deficit even further. It is known that insufficient physical activity has a major effect on the decline of functional fitness components, premature development of sarcopenia or frailty syndrome, threatening self-sufficiency, health and consequently quality of life. This is associated with an increased burden on the health care system and related social services, with implications for public budgets. The aim of this project is to eliminate the onset or premature manifestation of negative aspects of aging by prevention. The content is to research a unique intervention inspired by the principles of developmental kinesiology with a presumed positive effect on the health status and the development of a comprehensive exercise and educational program for older adults. The main planned result of the project is a methodological manual and a web application containing education and exercise program for both older adults as well healthcare professionals.
The project responds to the priorities of the Applied Health Research Program for the years 2020-2026 and its focus contributes to a long-term solution of the population aging issue. With regard to demographic change, health and social care systems will be unsustainable without the adoption of preventive measures by seniors themselves. Exercise-educational intervention can lead to lasting changes and can help seniors to actively and responsibly participate in the course of their own aging. Main objective: to reduce negative health related aspects of aging, resp. their premature manifestation, by a preventive exercise-educational program. Sub-objectives: - to develop a specifically targeted exercise-educational program; - to demonstrate effectiveness of the program on health and social related indicators; - to assess acceptability, sustainability and other personal contexts - to create a methodological manual and a web platform for home-dwelling as well as institutionalized older adults containing complex information for independent exercise (how, as well as why).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial of volunteers over 70 years of age
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Exercise program PERMANENTO inspired by developmental kinesiologyThe experimental group was educated and instructed and agaged in a 12-week exercise program - 15 minutes 6 times per week of complex daily routines delivered via on-line platform. |
| Contol group | No intervention | –The control group continued in regular daily activities and was offered the same intervention as the experimental group after the research trial. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- permanent residency in Prague
- being at least 70 years of age or older
- living independently at home
Key exclusion criteria (2 listed)
- significant mobility limitation
- any health condition preventing from physical activity
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 |
|---|---|---|
| Exercise program PERMANENTO inspired by developmental kinesiologyThe intervention is based on activation of reflexive movement patterns which ensures the original reflexive control of strength, mobility and stability. After birth, we cannot control our body movements - they are reflexes "hard-wired" into our brains and vitally important for proper development of our body (muscular system, vestibular system, sensory system, cardiovascular system or digestive system) as well as our brain and nervous systems. During early childhood, everything becomes integrated and works perfectly according to the original design. But this design is slowly abandoned due to for example sedentary lifestyle and replaced by compensatory movement patterns that are making us weaker and defective with all the consequences that are becoming more severe as we age. The aim is restore the original design and improve posture and other crucial components of functional fitness and move better and more. | Behavioural | Experimental group |
Primary outcome
Timed up-and go test
Time frame: Within a week prior the intervention and within a week after the intervention
Performance-based measure of functional mobility and balance in older adults.The test requires the participant to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair. The test's score is the time it takes the subject takes to complete the test. Lower score is better result.
Limits of stability on NeuroCom
Time frame: Within a week prior the intervention and within a week after the intervention
The Limits of Stability (LOS) test quantifies the maximum distance participant can lean own body (i.e. intentionally weight shift) in a given direction without losing balance, stepping, or reaching for assistance as would be required for function and gait. The scores for each parameter and movement direction are represented by a numeric value. Higher score is better result.
The Sensory Organization Test on NeuroCom
Time frame: Within a week prior the intervention and within a week after the intervention
The Sensory Organization Test (SOT) objectively identifies abnormalities in the patient's use of the three sensory systems that contribute to postural control: somatosensory, visual, and vestibular. The scores summarize the overall function of the three systems and the ability to resolve conflicting sensory inputs. Scores range from 0 to 100 (higher score, better result). Composite score identifies the presence of a balance control problem. Scores range from 0 to 100 (higher score, better result).
Body composition on InBody 720
Time frame: Within a week prior the intervention and within a week after the intervention
The multifrequency body composition analyser InBody720 analyses body composition via the method of bioelectrical impedance (DSM-BIA) for every part of the body using 6 different frequencies (1kHz, 5kHz, 50kHz, 250kHz, 500kHz, 1000kHz) in each one of the five parts of the body with the quadrupole 8-point tactile system. It provides wide range of outcomes (main focus on: Body fat mass - lower score, better result, Skeletal muscle mass - higher score, better result, Visceral Fat - lower score, better result).
Handgrip strength on dynanometr
Time frame: Within a week prior the intervention and within a week after the intervention
Handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. Participant is instructed to squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. Higher score, better result.
Perceived functional fitness and health status
Time frame: Within a week prior the intervention and within a week after the intervention
Measured by questions "In general, would you say your health is poor, fair, good, very good, or excellent?" and "In general, would you say your functional fitness is poor, fair, good, very good, or excellent?". Score are represented on 5-point scale: (1) Excellent, 2) Very Good, 3) Good, 4) Fair, or 5) Poor). Lower score, better result.
1 secondary outcome
Long-term sustainability
Time frame: 6 and 12 months after the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 42219155Machacova K, Steffl M, Bartova A, Novotna B, Holmerova I. Feasibility, Acceptability, and Preliminary Effects of the Online Exercise Program PERMANENTO in Older Adults: A Randomized Controlled Trial. J Aging Phys Act. 2026 May 29:1-9. doi: 10.1123/japa.2025-0180. Online ahead of print.
- 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.
Katerina Machacova principal investigator
Centre of Expertise in Longevity and Long-term care, Faculty of Humanities, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program PERMANENTO inspired by developmental kinesiology in people with Frailty and Sarcopenia, run by Charles University, Czech Republic at 1 site in Czechia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Nov 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up-and go test (time frame: Within a week prior the intervention and within a week after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06133894, which also lists 1 linked publication.
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 18 Nov 2023.