Functionally Impaired ElderlyHANC-PilotNCT02051725
Functional Impairments and Exercise in Older Adults With Low Physical Function,
A study testing Active life-style intervention in people with Functionally Impaired Elderly and Aging, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 76 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functionally Impaired Elderly, Aging
- What is being tested?
- Active life-style intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 76 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark, Department of Sports Science and Clinical Biomechanics
Odense, 5230 M
About this study
Official title: 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.
- Conditions
- Functionally Impaired Elderly, Aging
- Being tested
- Active life-style intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active life-style interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Changes from baseline to 12-week follow up
Cognitive function (Mini Mental State Examination and Digit Symbol Substitution Test)
Measured: 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.
Measured: Changes from baseline to 12-week follow up
Body composition including muscle, fat and bone quantity and quality
Measured: Changes from baseline to 12-week follow up
Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve function
Measured: 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)
Measured: Changes from baseline to 12-week follow up
Physical function including short and long distance walking speed, stair climbing, Short Physical Performance Battery Test
Measured: Changes from baseline to 12-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functionally Impaired ElderlyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Odense University Hospital, University of Pittsburgh, National Institute on Aging (NIA), Maastricht University, University of Washington
- Responsible party
- Principal investigator, Paolo Caserotti, University of Southern Denmark
- Investigators
- Paolo Caserotti, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051725
- Sponsor's protocol ID
- HANC 104-1.5-11
- Acronym
- HANC-Pilot
- Status last verified
- Jun 2016
- First submitted
- 3 Jan 2014
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39729186
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an "Active Life-style" Intervention in Older People With Low Physical Function: Effect on Functional Impairments, Pilot
- ClinicalTrials.gov ID
- NCT02051725
- Acronym / sponsor ID
- HANC-Pilot / HANC 104-1.5-11
- Conditions
- Functionally Impaired Elderly, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- European Union, Odense University Hospital, University of Pittsburgh, National Institute on Aging (NIA), Maastricht University, University of Washington
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active life-style intervention | Experimental | Other: Active life-style interventionThe "active life-style intervention" is designed as 12-week structured and progressive heavy-resistance power training combined with recommended everyday physical activity. |
| 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. |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active life-style intervention | Other | Active life-style intervention |
Primary outcome
Changes in leg press muscle power
Time frame: 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
7 secondary outcomes
Physical activity, sedentary behaviour and sleep quality (objectively assessed by accelerometry)
Time frame: Changes from baseline to 12-week follow up
Cognitive function (Mini Mental State Examination and Digit Symbol Substitution Test)
Time frame: 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.
Time frame: Changes from baseline to 12-week follow up
Body composition including muscle, fat and bone quantity and quality
Time frame: Changes from baseline to 12-week follow up
Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve function
Time frame: 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)
Time frame: Changes from baseline to 12-week follow up
Physical function including short and long distance walking speed, stair climbing, Short Physical Performance Battery Test
Time frame: Changes from baseline to 12-week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Derived from this study: PubMed 39729186Muollo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Caserotti, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active life-style intervention in people with Functionally Impaired Elderly and Aging, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in leg press muscle power (time frame: Changes in muscle power from baseline to 12-week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.