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Completed

NCT Number: NCT04798404

Integrated Care Analysis Response to Exercise in Community-dwelling Elders

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal exercise intervention

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Integrating a Prevention Care Path Into Daily Life of Elders With Mobility Disability Risk: Introducing a Predictive Model to a Functional Exercise Response

Acronym: ICARE

Important dates

Study start
2017
Primary completion
2017
Study completion
2020
First posted
Mar 15, 2021
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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