Functional Impairments and Exercise in Older Adults With Low Physical Function,

NCT ID: NCT02051725

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-06-30

Brief Summary

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* Aging is associated with a progressive and generalized deterioration of physiologic systems and greater incidence of chronic conditions, which ultimately translates into functional impairment, disability and dependency.
* Physical activity and exercise have been recognized as key pillars for the management of chronic diseases in support of medical treatment, and essential to increase physiologic function, but there is only limited evidence indicating increased physical function, following exercise interventions. One of the greatest challenges in the science of aging and exercise is to understand whether and to which extent exercise and active life-style may postpone the onset of disability and/or reverse physical impairments.
* Maintenance/improvements of physical function and mobility should be considered as primary targets for independent living, active engagement in societal challenges, and, more in general, when promoting "active ageing".
* The aim of this study is to collect preliminary data to identify the feasibility and sustainability of an "active life-style intervention" in older adults with reduced mobility receiving a preventive home visit from the public health care authority.
* This study will represent the base for a larger phase III parallel group study implemented in the public health care setting, with the specific aim of improving physical function and delay the onset of functional impairment in older adults.

Detailed Description

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Conditions

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Functionally Impaired Elderly Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Active life-style intervention

The "active life-style intervention" is designed as 12-week structured and progressive heavy-resistance power training combined with recommended everyday physical activity.

Group Type EXPERIMENTAL

Active life-style intervention

Intervention Type OTHER

Control

The control group is offered to enroll in the same active life-style intervention after the end of the 12-week control period. During the control period this group is asked to maintain the habitual life style.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active life-style intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Older adults (age 76 years and above) receiving a visit from the personnel of preventive home unit of municipality of Odense (DK)
* Mini Mental State Examination \> = 21
* Self-selected gait speed \< 0,9 m/s
* Ability to self-transport to the training facility

Exclusion Criteria

* Unstable medical conditions including ECG abnormalities, uncontrolled hypertension, terminal and critical chronic conditions (e.g. cancer, severe heart failure)
* Amputation or other severe physical impairments prohibiting participation in the active life-style intervention
* Refusal to wear accelerometer
Minimum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Union

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Paolo Caserotti

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Caserotti, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Locations

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University of Southern Denmark, Department of Sports Science and Clinical Biomechanics

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Muollo V, Hvid LG, Shanbhogue VV, Steinhauser V, Caporossi D, Dimauro I, Andersen MS, Fantini C, Grazioli E, Strotmeyer ES, Caserotti P. Effects of 12-week power training on bone in mobility-limited older adults: randomised controlled trial. Arch Osteoporos. 2024 Dec 27;20(1):5. doi: 10.1007/s11657-024-01487-z.

Reference Type DERIVED
PMID: 39729186 (View on PubMed)

Other Identifiers

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HANC 104-1.5-11

Identifier Type: -

Identifier Source: org_study_id

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