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

Implementation of an Active Life-style Intervention in Older People With Low Physical Function: Effect on Functional Impairments, Pilot

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02051725
Acronym
HANC-Pilot
Enrollment
65
Registered
2014-01-31
Start date
2013-11-30
Completion date
2015-06-30
Last updated
2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Functionally Impaired Elderly

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.

Interventions

OTHERActive life-style intervention

Sponsors

European Union
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Maastricht University
CollaboratorOTHER
University of Washington
CollaboratorOTHER
University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
76 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in leg press muscle powerChanges in muscle power from baseline to 12-week follow upMuscle power will be assessed on the dominant leg with the Notthingham power rig and expressed as Watt/kg. Subjects are sitting with

Secondary

MeasureTime frame
Physical activity, sedentary behaviour and sleep quality (objectively assessed by accelerometry)Changes from baseline to 12-week follow up
Cognitive function (Mini Mental State Examination and Digit Symbol Substitution Test)Changes from baseline to 12-week follow up
Self-report Health-related measures including quality of life, pain, depression, sleep quality, fatigue, activities of daily living, anxiety.Changes from baseline to 12-week follow up
Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve functionChanges from baseline to 12-week follow up
Selected blood biomarkers related to physical, muscle-skeletal and cognitive function (e.g. C reactive protein, insulin like growth factor, IL-6, BDNF)Changes from baseline to 12-week follow up
Physical function including short and long distance walking speed, stair climbing, Short Physical Performance Battery TestChanges from baseline to 12-week follow up
Body composition including muscle, fat and bone quantity and qualityChanges from baseline to 12-week follow up

Other

MeasureTime frame
Use of public health care resources5-year retrospectively and 3-year prospectively

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026