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

NCT02051725 | Completed

• 1 other identifier: HANC 104-1.5-11
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Functionally Impaired Elderly; Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Other Outcomes (1)

• Use of public health care resources

  5-year retrospectively and 3-year prospectively

Study Arms (2)

Active life-style intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Active life-style intervention OTHER

Active life-style intervention

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Odense, 5230 M, Denmark

Location

Related Publications (1)

• Muollo V, Hvid LG, Shanbhogue VV, Steinhauser V, Caporossi D, Dimauro I, Andersen MS, Fantini C, Grazioli E, Strotmeyer ES, Caserotti P. Effects of 12-week power training on bone in mobility-limited older adults: randomised controlled trial. Arch Osteoporos. 2024 Dec 27;20(1):5. doi: 10.1007/s11657-024-01487-z.

  PMID: 39729186 DERIVED

Study Officials

• Paolo Caserotti, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 31, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

DK (1)