Physical ActivityICARENCT04798404
Integrated Care Analysis Response to Exercise in Community-dwelling Elders
An observational study of Physical Activity and Gerontology, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
One of the main challenges of ageing is to prevent the onset of mobility disability and its co-morbidities. Screening the risk of mobility disability in community-dwelling elders is therefore very important and at the uppermost for the care of sarcopenia and frailty. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Gerontology
- What is being tested?
- Multimodal exercise intervention
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Feb 2020
- Phase
- Observational
- 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
Study population: Community-dwelling elders diagnosed with risk mobility disability risk and who participated in 20 collective sessions of resistance training.
Who may be able to join
- Aged ≥ 70 years old
- Diagnosed with mobility disability risk during the initial assessment (sedentary or/and pre-frail/frail or/and sarcopenia at least probable)
- Have completed the 20 collective sessions
- Have been reassessed after 3 months of intervention
Who cannot join
- Baseline SPPB < 5
- Erroneous clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating a Prevention Care Path Into Daily Life of Elders With Mobility Disability Risk: Introducing a Predictive Model to a Functional Exercise Response
One of the main challenges of ageing is to prevent the onset of mobility disability and its co-morbidities. Screening the risk of mobility disability in community-dwelling elders is therefore very important and at the uppermost for the care of sarcopenia and frailty. A multicomponent intervention, integrating multidisciplinary actions and combining physical exercise and nutrition, is recognized as an effective therapy for the care of mobility disability risk factors. The diagnosis of either pre-frail/frailty and/or sarcopenia at least probable is sufficient to trigger a sustained intervention as it can prevent the onset of mobility disability. Therefore, it is difficult to identify the best responder for this type of care path. As a result, studies have been interested in exploring the predictive factors related to the functional response to exercise within lifestyle interventions. It has been shown that SPPB provides useful information when associated with demographic or physical activity factors. Those predictions are reliable to an ageing population with a SPPB ≤9 but it is still unknown if these reports are reproducible to older adults with high baseline physical function. Therefore, we hypothesized that a more inclusive SPPB score at baseline could also be related to other factors to predict the functional response to exercise. We assumed that strength, age, sex or body mass index could be interesting to elicit better predictions. It is an important issue for the development of targeted-interventions and specific care orientations.
The training has to be established through an accurate schedule to optimize the response to exercise. However, it is difficult to make consensus on the best method to apply, especially for elders with mobility disability risk. Hence, the present study also focus on a specific training method planned toward different exercises modes. We aimed to propose a training with cost-effective material and the absence of machines to transpose it into daily life participants. We expected to observe benefits on physical performance after this exercise intervention.
- Conditions
- Physical Activity, Gerontology
- Being tested
- Multimodal exercise intervention
- Keywords
- elders, mobility, prevention, predictive model, resistance training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal exercise interventionOther
The intervention conducted was a progressive multicomponent training protocol. The training consisted on 2 collective sessions of 1h per week, during 10 weeks. Sessions involved functional exercises, muscular reinforcement performed at body-weight or with small materials (elastic bands or dumbbells), balance, and adapted sport and physical activities. Progression was based on an increase in workload (or in muscle strains). The workload was considered as the interaction of intensity and volume of exercise (set x repetitions). Intensity was based on effort tolerance, modulate by contraction regimen, velocity and load (elastic bands stiffness). Participants were encouraged to reproduce exercises at home when they were performed easily in supervised collective sessions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention in 20 collective sessions | 104 elders recruited among the community (mean age: 82.1 ± 5.7, 72 women and 32 men), diagnosed in initial consultation with mobility disability risk (sedentary or/and pre-frail/frail or/and sarcopenia at least probable) who participated in 20 collective sessions twice a week and two hours per week, and have been seen for reassessment in final consultation. Receives: Other: Multimodal exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (score /12)
The use of SPPB is widely recognized for its ability to accurately assess the risk of mobility disability in elderly. It is based on the result of three assessments; static balance test, the ability to perform five chair lifts as quickly as possible and a walking speed test measured over four or six meters. SPPB give a score for 0 to 12 with an increased risk of mobility disability for a score less or equal to 8.
Measured: Change in the SPPB score at 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jan 2017
- Primary completion1 Jan 2017
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798404
- Sponsor's protocol ID
- 69HCL20_1091
- Acronym
- ICARE
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating a Prevention Care Path Into Daily Life of Elders With Mobility Disability Risk: Introducing a Predictive Model to a Functional Exercise Response
- ClinicalTrials.gov ID
- NCT04798404
- Acronym / sponsor ID
- ICARE / 69HCL20_1091
- Conditions
- Physical Activity, Gerontology
- Keywords
- elders, mobility, prevention, predictive model, resistance training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 15 Mar 2021 (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.
One of the main challenges of ageing is to prevent the onset of mobility disability and its co-morbidities. Screening the risk of mobility disability in community-dwelling elders is therefore very important and at the uppermost for the care of sarcopenia and frailty. A multicomponent intervention, integrating multidisciplinary actions and combining physical exercise and nutrition, is recognized as an effective therapy for the care of mobility disability risk factors. The diagnosis of either pre-frail/frailty and/or sarcopenia at least probable is sufficient to trigger a sustained intervention as it can prevent the onset of mobility disability. Therefore, it is difficult to identify the best responder for this type of care path. As a result, studies have been interested in exploring the predictive factors related to the functional response to exercise within lifestyle interventions. It has been shown that SPPB provides useful information when associated with demographic or physical activity factors. Those predictions are reliable to an ageing population with a SPPB ≤9 but it is still unknown if these reports are reproducible to older adults with high baseline physical function. Therefore, we hypothesized that a more inclusive SPPB score at baseline could also be related to other factors to predict the functional response to exercise. We assumed that strength, age, sex or body mass index could be interesting to elicit better predictions. It is an important issue for the development of targeted-interventions and specific care orientations.
The training has to be established through an accurate schedule to optimize the response to exercise. However, it is difficult to make consensus on the best method to apply, especially for elders with mobility disability risk. Hence, the present study also focus on a specific training method planned toward different exercises modes. We aimed to propose a training with cost-effective material and the absence of machines to transpose it into daily life participants. We expected to observe benefits on physical performance after this exercise intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention in 20 collective sessions | – | Other: Multimodal exercise intervention104 elders recruited among the community (mean age: 82.1 ± 5.7, 72 women and 32 men), diagnosed in initial consultation with mobility disability risk (sedentary or/and pre-frail/frail or/and sarcopenia at least probable) who participated in 20 collective sessions twice a week and two hours per week, and have been seen for reassessment in final consultation. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling elders diagnosed with risk mobility disability risk and who participated in 20 collective sessions of resistance training.
Key inclusion criteria (4 listed)
- Aged ≥ 70 years old
- Diagnosed with mobility disability risk during the initial assessment (sedentary or/and pre-frail/frail or/and sarcopenia at least probable)
- Have completed the 20 collective sessions
- Have been reassessed after 3 months of intervention
Key exclusion criteria (2 listed)
- Baseline SPPB < 5
- Erroneous clinical data
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 |
|---|---|---|
| Multimodal exercise interventionThe intervention conducted was a progressive multicomponent training protocol. The training consisted on 2 collective sessions of 1h per week, during 10 weeks. Sessions involved functional exercises, muscular reinforcement performed at body-weight or with small materials (elastic bands or dumbbells), balance, and adapted sport and physical activities. Progression was based on an increase in workload (or in muscle strains). The workload was considered as the interaction of intensity and volume of exercise (set x repetitions). Intensity was based on effort tolerance, modulate by contraction regimen, velocity and load (elastic bands stiffness). Participants were encouraged to reproduce exercises at home when they were performed easily in supervised collective sessions. | Other | Exercise Intervention in 20 collective sessions |
Primary outcome
Short Physical Performance Battery (score /12)
Time frame: Change in the SPPB score at 3 months of intervention
The use of SPPB is widely recognized for its ability to accurately assess the risk of mobility disability in elderly. It is based on the result of three assessments; static balance test, the ability to perform five chair lifts as quickly as possible and a walking speed test measured over four or six meters. SPPB give a score for 0 to 12 with an increased risk of mobility disability for a score less or equal to 8.
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 15 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Gerontology, run by Hospices Civils de Lyon at 1 site in France.
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 4 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 15 Mar 2021. 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 France. 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?
Short Physical Performance Battery (score /12) (time frame: Change in the SPPB score at 3 months of intervention). 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 15 Mar 2021.