Integrated Care Analysis Response to Exercise in Community-dwelling Elders

Physical Activity Clinical Trial

— ICARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04798404
• Other study ID #: 69HCL20_1091
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 1, 2020
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gerontology
• Physical Activity

Intervention

Other:
• Multimodal exercise intervention
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.

Locations

Country	Name	City	State
France	Hôpital Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in the SPPB score at 3 months of intervention