AtrophyPhase 3NCT00267839
Effect of Exercise on Risk-factors of Elderly Women
A Phase 3 study testing physical exercise, wellness in people with Atrophy, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrophy
- What is being tested?
- physical exercise, wellness
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 246 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2006to Mar 2008
- Phase
- Phase 3
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community living Caucasian woman ≥ 65 years; live expectation > 2 years
Who cannot join
- secondary osteoporosis
- CVD-events including stroke
- Participation in other studies
- Medication with impact on bone during the last 2 years:
- bisphosphonates
- parathormone
Show all 15Show fewer
- strontium
- HRT, anabolic steroids
- calcitonin
- natriumflourides
- active Vit-D-metabolites
- cortisone > 5 mg/d
- medication with impact on falls
- low physical performance (<50 Watt during ergometry)
- excessive alcohol-intake
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Institute of Medical Physics University of Erlangen-Nurnberg
Erlangen, 91052
Institute of Medical Physics
Erlangen, 91052
About this study
Official title: Effects of Exercise on Multiple Risk Factors and Health Costs in Community Living Elderly Women. The Senior Fitness and Prevention Study (SEFIP)
The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.
Read the detailed description
The human aging process is associated with a significant increase of risk factors (i.e. osteoporosis, coronary heard disease, diabetes) and a decline in neuromuscular function impacting independence of the subject. Osteoporosis, diabetes type II and arteriosclerosis are diseases known to correlate with age. Participating in regular sport activities elicits numerous favorable effects that contribute to "healthy aging". Unfortunately all existing studies which focus on specific diseases or conditions favour dedicated exercise regimes. However, the complex risk factor scenario of older adults requires multi-purpose exercise programs with impact on all relevant risks. Furthermore so far no exercise study longitudinally determines the effect of an ambulatory exercise program on health cost considering the specific health policy framework of Germany. We hypothesize that regular exercise
- significantly impact relevant osteoporosis, cardiovascular diseases and diabetes risk factors in elderly subjects
- significantly reduces health costs in elderly community living women
- Conditions
- Atrophy
- Being tested
- physical exercise, wellness
- Keywords
- exercise, intervention, elderly woman, risk factors, health costs, Osteoporosis, cardiovascular diseases, diabetes, Higher Age
- Medical subject headings
- Atrophy, Motor Activity, Osteoporosis, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exercise, wellnessBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
health costs after 18 months
Measured: baseline 18 month control
falls after 18 months
Measured: daily records, analysis after 18 months
Bone parameters after 6, 12 and 18 months
Measured: baseline, 6, 12, 18 month-control
Secondary outcomes (3)
Functional status after 6, 12, and 18 months
CHD- and diabetes-risk-factors (bodyfat, blood lipids, glucose, blood pressure) after 6, 12 and 18 months
Quality of live after 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtrophyStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V., Kassenärztliche Vereinigung Bayern, Siemens-Betriebskrankenkasse
- Responsible party
- Sponsor
- Investigators
- Willi A Kalender, PhD, Study chair, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267839
- Sponsor's protocol ID
- D-ER-OFZ-200501
- Status last verified
- May 2015
- First submitted
- 20 Dec 2005
- Last updated
- 1 Jun 2015
- Results posted
- No
Publications
Kemmler W, von Stengel S, Weineck J, Lauber D, Kalender W, Engelke K. Exercise effects on menopausal risk factors of early postmenopausal women: 3-yr Erlangen fitness osteoporosis prevention study results. Med Sci Sports Exerc. 2005 Feb;37(2):194-203. doi: 10.1249/01.mss.0000152678.20239.76.
PubMed 15692313Kemmler W, von Stengel S, Engelke K, Haberle L, Mayhew JL, Kalender WA. Exercise, body composition, and functional ability: a randomized controlled trial. Am J Prev Med. 2010 Mar;38(3):279-87. doi: 10.1016/j.amepre.2009.10.042.
PubMed 20171529Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA. Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study. Arch Intern Med. 2010 Jan 25;170(2):179-85. doi: 10.1001/archinternmed.2009.499.
PubMed 20101013
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Multiple Risk Factors and Health Costs in Community Living Elderly Women. The Senior Fitness and Prevention Study (SEFIP)
- ClinicalTrials.gov ID
- NCT00267839
- Acronym / sponsor ID
- D-ER-OFZ-200501
- Conditions
- Atrophy
- Keywords
- exercise, intervention, elderly woman, risk factors, health costs, Osteoporosis, cardiovascular diseases, diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V., Kassenärztliche Vereinigung Bayern, Siemens-Betriebskrankenkasse
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 21 Dec 2005 (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.
The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.
Detailed description
The human aging process is associated with a significant increase of risk factors (i.e. osteoporosis, coronary heard disease, diabetes) and a decline in neuromuscular function impacting independence of the subject. Osteoporosis, diabetes type II and arteriosclerosis are diseases known to correlate with age. Participating in regular sport activities elicits numerous favorable effects that contribute to "healthy aging". Unfortunately all existing studies which focus on specific diseases or conditions favour dedicated exercise regimes. However, the complex risk factor scenario of older adults requires multi-purpose exercise programs with impact on all relevant risks. Furthermore so far no exercise study longitudinally determines the effect of an ambulatory exercise program on health cost considering the specific health policy framework of Germany. We hypothesize that regular exercise
- significantly impact relevant osteoporosis, cardiovascular diseases and diabetes risk factors in elderly subjects
- significantly reduces health costs in elderly community living women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Community living Caucasian woman ≥ 65 years; live expectation > 2 years
Key exclusion criteria (15 listed)
- secondary osteoporosis
- CVD-events including stroke
- Participation in other studies
- Medication with impact on bone during the last 2 years:
- medication with impact on falls
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 |
|---|---|---|
| physical exercise, wellness | Behavioural | – |
Primary outcome
health costs after 18 months
Time frame: baseline 18 month control
falls after 18 months
Time frame: daily records, analysis after 18 months
Bone parameters after 6, 12 and 18 months
Time frame: baseline, 6, 12, 18 month-control
3 secondary outcomes
Functional status after 6, 12, and 18 months
CHD- and diabetes-risk-factors (bodyfat, blood lipids, glucose, blood pressure) after 6, 12 and 18 months
Quality of live after 12 and 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Background: PubMed 15692313Kemmler W, von Stengel S, Weineck J, Lauber D, Kalender W, Engelke K. Exercise effects on menopausal risk factors of early postmenopausal women: 3-yr Erlangen fitness osteoporosis prevention study results. Med Sci Sports Exerc. 2005 Feb;37(2):194-203. doi: 10.1249/01.mss.0000152678.20239.76.
- Derived from this study: PubMed 20171529Kemmler W, von Stengel S, Engelke K, Haberle L, Mayhew JL, Kalender WA. Exercise, body composition, and functional ability: a randomized controlled trial. Am J Prev Med. 2010 Mar;38(3):279-87. doi: 10.1016/j.amepre.2009.10.042.
- Derived from this study: PubMed 20101013Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA. Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study. Arch Intern Med. 2010 Jan 25;170(2):179-85. doi: 10.1001/archinternmed.2009.499.
- Related InfoLink provided by the sponsor.
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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.
Willi A Kalender, PhD study chair
University of Erlangen-Nürnberg Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing physical exercise, wellness in people with Atrophy, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
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 1 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
health costs after 18 months (time frame: baseline 18 month control). The study lists 3 primary outcomes in all. 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 NCT00267839, which also lists 3 linked publications.
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 1 Jun 2015.