Clinical trial NCT04798404: Integrated Care Analysis Response to Exercise in Community-dwelling Elders
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Gerontology
Keywords: elders
mobility
prevention
predictive model
resistance training
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 104
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling elders diagnosed with risk mobility disability risk and who participated in 20 collective sessions of resistance training.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Baseline SPPB \< 5
* Erroneous clinical data

Primary outcomes:
measure: Short Physical Performance Battery (score /12)
timeFrame: Change in the SPPB score at 3 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
References: