NCT04798404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 15, 2021

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

February 23, 2021

Last Update Submit

March 12, 2021

Conditions

Keywords

eldersmobilitypreventionpredictive modelresistance training

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: Multimodal exercise intervention

Interventions

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.

Exercise Intervention in 20 collective sessions

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling elders diagnosed with risk mobility disability risk and who participated in 20 collective sessions of resistance training.

You may qualify if:

  • 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

You may not qualify if:

  • Baseline SPPB \< 5
  • Erroneous clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 15, 2021

Study Start

January 1, 2017

Primary Completion

January 1, 2017

Study Completion

February 1, 2020

Last Updated

March 15, 2021

Record last verified: 2021-02

Locations