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OpenTrials
Completed

NCT Number: NCT02051725

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

* 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.

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Key information

Age range

76 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Odense, 5230 M, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Active life-style intervention

Other

Primary outcomes

  1. Changes in leg press muscle power

    Time frame: Changes in muscle power from baseline to 12-week follow up

    Muscle power will be assessed on the dominant leg with the Notthingham power rig and expressed as Watt/kg. Subjects are sitting with

Secondary outcomes

  1. Physical activity, sedentary behaviour and sleep quality (objectively assessed by accelerometry)

    Time frame: Changes from baseline to 12-week follow up

  2. Cognitive function (Mini Mental State Examination and Digit Symbol Substitution Test)

    Time frame: Changes from baseline to 12-week follow up

  3. Self-report Health-related measures including quality of life, pain, depression, sleep quality, fatigue, activities of daily living, anxiety.

    Time frame: Changes from baseline to 12-week follow up

  4. Body composition including muscle, fat and bone quantity and quality

    Time frame: Changes from baseline to 12-week follow up

  5. Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve function

    Time frame: Changes from baseline to 12-week follow up

  6. Selected blood biomarkers related to physical, muscle-skeletal and cognitive function (e.g. C reactive protein, insulin like growth factor, IL-6, BDNF)

    Time frame: Changes from baseline to 12-week follow up

  7. Physical function including short and long distance walking speed, stair climbing, Short Physical Performance Battery Test

    Time frame: Changes from baseline to 12-week follow up

Other outcomes

  1. Use of public health care resources

    Time frame: 5-year retrospectively and 3-year prospectively

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • European Union
  • Maastricht University
  • National Institute on Aging (NIA)
  • Odense University Hospital
  • University of Pittsburgh
  • University of Washington

Registry information

Official study title

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

Acronym: HANC-Pilot

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2014
Registry last updated
Jun 28, 2016

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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