HANC-Pilot: Functional Impairments and Exercise in Older Adults With Low Physical Function,

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT02051725
Collaborator
European Union (Other), Odense University Hospital (Other), University of Pittsburgh (Other), National Institute on Aging (NIA) (NIH), Maastricht University (Other), University of Washington (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Active life-style intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Implementation of an "Active Life-style" Intervention in Older People With Low Physical Function: Effect on Functional Impairments, Pilot
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Active life-style intervention

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Changes in leg press muscle power [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 Outcome Measures

  1. Physical activity, sedentary behaviour and sleep quality (objectively assessed by accelerometry) [Changes from baseline to 12-week follow up]

  2. Cognitive function (Mini Mental State Examination and Digit Symbol Substitution Test) [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. [Changes from baseline to 12-week follow up]

  4. Body composition including muscle, fat and bone quantity and quality [Changes from baseline to 12-week follow up]

  5. Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve function [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) [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 [Changes from baseline to 12-week follow up]

Other Outcome Measures

  1. Use of public health care resources [5-year retrospectively and 3-year prospectively]

Eligibility Criteria

Criteria

Ages Eligible for Study:
76 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern Denmark, Department of Sports Science and Clinical Biomechanics Odense Denmark 5230 M

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Paolo Caserotti, PhD, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Caserotti, Assistant Professor, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT02051725
Other Study ID Numbers:
  • HANC 104-1.5-11
First Posted:
Jan 31, 2014
Last Update Posted:
Jun 28, 2016
Last Verified:
Jun 1, 2016

Study Results

No Results Posted as of Jun 28, 2016