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

Study Overview
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Brief Summary
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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.

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

Conditions
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Functionally Impaired Elderly, Aging

Intervention / Treatment
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* Other: Active life-style intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active life-style intervention<br>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<br> <br> |
| No Intervention: Control<br>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?
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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 | Measure Description | 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 |