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

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

• 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.

Study Overview

• Status: Completed
• Conditions: Aging; Functionally Impaired Elderly
• Intervention / Treatment: Other: Active life-style intervention

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5230 M
    • University of Southern Denmark, Department of Sports Science and Clinical Biomechanics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 76 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in leg press muscle power	Muscle power will be assessed on the dominant leg with the Notthingham power rig and expressed as Watt/kg. Subjects are sitting with	Changes in muscle power from baseline to 12-week follow up

Secondary Outcome Measures

Outcome Measure	Time 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
Body composition including muscle, fat and bone quantity and quality	Changes from baseline to 12-week follow up
Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve function	Changes 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 Test	Changes from baseline to 12-week follow up

Other Outcome Measures

Outcome Measure	Time Frame
Use of public health care resources	5-year retrospectively and 3-year prospectively

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital; University of Pittsburgh; National Institute on Aging (NIA); University of Washington; Maastricht University; European Union
• Investigators: Principal Investigator: Paolo Caserotti, PhD, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HANC 104-1.5-11