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

Aging Clinical Trial

— HANC-Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051725
• Other study ID #: HANC 104-1.5-11
• Status: Completed
• Phase: N/A
• First received: January 3, 2014
• Last updated: June 27, 2016
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 76 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging
• Functionally Impaired Elderly

Intervention

Other:
• Active life-style intervention

Locations

Country	Name	City	State
Denmark	University of Southern Denmark, Department of Sports Science and Clinical Biomechanics	Odense

Sponsors (7)

Lead Sponsor	Collaborator
University of Southern Denmark	European Union, Maastricht University, National Institute on Aging (NIA), Odense University Hospital, University of Pittsburgh, University of Washington

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of public health care resources		5-year retrospectively and 3-year prospectively	No
Primary	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	No
Secondary	Physical activity, sedentary behaviour and sleep quality (objectively assessed by accelerometry)		Changes from baseline to 12-week follow up	No
Secondary	Cognitive function (Mini Mental State Examination and Digit Symbol Substitution Test)		Changes from baseline to 12-week follow up	No
Secondary	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	No
Secondary	Body composition including muscle, fat and bone quantity and quality		Changes from baseline to 12-week follow up	No
Secondary	Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve function		Changes from baseline to 12-week follow up	No
Secondary	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	No
Secondary	Physical function including short and long distance walking speed, stair climbing, Short Physical Performance Battery Test		Changes from baseline to 12-week follow up	No