Clinical trial NCT02051725: Functional Impairments and Exercise in Older Adults With Low Physical Function,
Official title: Implementation of an "Active Life-style" Intervention in Older People With Low Physical Function: Effect on Functional Impairments, Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functionally Impaired Elderly
Aging
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: European Union
name: Odense University Hospital
name: University of Pittsburgh
name: National Institute on Aging (NIA)
name: Maastricht University
name: University of Washington
First posted: 2014-01-31
Enrollment: 65
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in leg press muscle power
timeFrame: Changes in muscle power from baseline to 12-week follow up
Secondary outcomes:
measure: Physical activity, sedentary behaviour and sleep quality (objectively assessed by accelerometry)
timeFrame: Changes from baseline to 12-week follow up
measure: Cognitive function (Mini Mental State Examination and Digit Symbol Substitution Test)
timeFrame: Changes from baseline to 12-week follow up
measure: Self-report Health-related measures including quality of life, pain, depression, sleep quality, fatigue, activities of daily living, anxiety.
timeFrame: Changes from baseline to 12-week follow up
measure: Body composition including muscle, fat and bone quantity and quality
timeFrame: Changes from baseline to 12-week follow up
measure: Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve function
timeFrame: Changes from baseline to 12-week follow up
measure: Selected blood biomarkers related to physical, muscle-skeletal and cognitive function (e.g. C reactive protein, insulin like growth factor, IL-6, BDNF)
timeFrame: Changes from baseline to 12-week follow up
measure: Physical function including short and long distance walking speed, stair climbing, Short Physical Performance Battery Test
timeFrame: Changes from baseline to 12-week follow up
Other outcomes:
measure: Use of public health care resources
timeFrame: 5-year retrospectively and 3-year prospectively
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark, Department of Sports Science and Clinical Biomechanics
Study officials:
affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Paolo Caserotti, PhD
role: PRINCIPAL_INVESTIGATOR
References: