AgingNCT01775111
Influence of Strength Training and Protein Supplementation on Fitness of Institutionalized Elderly
A study testing Cognitive Training, Strength Training and FortiFit in people with Aging, run by University of Vienna at 1 site in Austria.
Trial summary
The aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of strength training (2x/week for 6 months) with and without additional dietary supplementation (protein-enriched) on muscle strength, function and mass, oxidative stress parameters and the immune… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Cognitive Training, Strength Training and FortiFit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2012to Dec 2013
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State >23)
- Ability to walk 10 meters independently (without orthopaedic devices)
- 4 or more points at the Short Physical Performance Battery
Who cannot join
- Chronic diseases, which contraindicate a medical training therapy
- Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
- Diabetic retinopathy
- Manifest osteoporosis
- Regular use of cortisone-containing drugs
- Regular strength training (> 1x / week) in the last 6 months before inclusion
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University of Vienna, Centre of Sports Science and University Sports
Vienna, State of Vienna, 1150
Barbara Wessner, Ass.-Prof. DI Dr., +4314277 ext. 28772, barbara.wessner@univie.ac.at
Barbara Wessner, Ass.-Prof. DI Dr.
About this study
Official title: Influence of Strength Training and Nutritional Supplementation on Physical Performance and Well-being of Older People in Pensioner Homes
The aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of strength training (2x/week for 6 months) with and without additional dietary supplementation (protein-enriched) on muscle strength, function and mass, oxidative stress parameters and the immune system in elderly institutionalized persons.
The participants (n = 120) are recruited from Viennese senior residencies (Kuratorium Wiener Pensionistenwohnheime). After a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 intervention groups (cognitive training, strength training, strength training + supplement).
Read more
Study participants are eligible if they are male or female with an age over 65 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the medical training therapy, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months.
Primary outcome measure is the change in isokinetic torque of knee extensors. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters. The change in muscle signaling pathways will be assessed from muscle biopsies.
- Conditions
- Aging
- Being tested
- Cognitive Training, Strength Training, FortiFit
- Keywords
- strength training, protein supplementation, sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Strength TrainingBehavioural
FortiFitDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Sham comparator | Cognitive Training (riddles, skill games, ...) is performed twice a week in small groups Receives: Behavioral: Cognitive Training |
| Strength Training | Experimental | Progressive strength training is applied, meaning that the intensity is adjusted continuously in order to obtain a sufficient training stimulus. Exercises are chosen to involve the major muscle groups and are performed by using the own body weight or elastic bands. Receives: Behavioral: Strength Training |
| Strength Training and Supplement | Experimental | In addition to strength training as described above, participants receive a water-soluble dietary supplement 9x/week (FortiFit, Nutricia) consisting of 20.7 g of protein (56 En%, 19.7 g whey protein, 3 g leucine,> 10 g essential amino acids), 9.3 g carbohydrates (25 En%, 0.8 BE), 3.0 g fat (18 En%), 1.2 g fiber (2 En%), 800 IU (20μg) of vitamin D, 250mg calcium, vitamins B6 and B12, folic acid and magnesium. Receives: Behavioral: Strength Training; Dietary Supplement: FortiFit |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in isokinetic torque of knee extensors
Measured: baseline and 6 months
Secondary outcomes (7)
change from baseline in 6min walking test
Measured: baseline and 6 months
change from baseline in handgrip strength
Measured: baseline and 6 months
change from baseline in single leg balance stand
Measured: baseline and 6 months
change from baseline in lean body mass
Measured: baseline and 6 months
change from baseline in muscular myostatin expression
Measured: baseline and 6 months
change from baseline in DNA strand breaks
Measured: baseline and 6 months
change from baseline in high-sensitive C reactive protein
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
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 AgingStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Franz Josef Hospital
- Responsible party
- Principal investigator, Ass.-Prof. DI Dr. Barbara Wessner, University of Vienna
- Investigators
- Barbara Wessner, Ass.-Prof. DI Dr., Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775111
- Sponsor's protocol ID
- ActiveAgeing
- Status last verified
- Jan 2013
- First submitted
- 21 Jan 2013
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Franzke B, Schober-Halper B, Hofmann M, Oesen S, Tosevska A, Henriksen T, Poulsen HE, Strasser EM, Wessner B, Wagner KH. Age and the effect of exercise, nutrition and cognitive training on oxidative stress - The Vienna Active Aging Study (VAAS), a randomized controlled trial. Free Radic Biol Med. 2018 Jun;121:69-77. doi: 10.1016/j.freeradbiomed.2018.04.565. Epub 2018 Apr 24.
PubMed 29698742Tosevska A, Franzke B, Hofmann M, Vierheilig I, Schober-Halper B, Oesen S, Neubauer O, Wessner B, Wagner KH. Circulating cell-free DNA, telomere length and bilirubin in the Vienna Active Ageing Study: exploratory analysis of a randomized, controlled trial. Sci Rep. 2016 Dec 1;6:38084. doi: 10.1038/srep38084.
PubMed 27905522Grimpampi E, Oesen S, Halper B, Hofmann M, Wessner B, Mazza C. Reliability of gait variability assessment in older individuals during a six-minute walk test. J Biomech. 2015 Nov 26;48(15):4185-4189. doi: 10.1016/j.jbiomech.2015.10.008. Epub 2015 Oct 20.
PubMed 26515246
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Strength Training and Nutritional Supplementation on Physical Performance and Well-being of Older People in Pensioner Homes
- ClinicalTrials.gov ID
- NCT01775111
- Acronym / sponsor ID
- ActiveAgeing
- Conditions
- Aging
- Keywords
- strength training, protein supplementation, sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Collaborators
- Kaiser Franz Josef Hospital
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- First posted
- 24 Jan 2013 (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 aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of strength training (2x/week for 6 months) with and without additional dietary supplementation (protein-enriched) on muscle strength, function and mass, oxidative stress parameters and the immune system in elderly institutionalized persons.
The participants (n = 120) are recruited from Viennese senior residencies (Kuratorium Wiener Pensionistenwohnheime). After a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 intervention groups (cognitive training, strength training, strength training + supplement).
Study participants are eligible if they are male or female with an age over 65 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the medical training therapy, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months.
Primary outcome measure is the change in isokinetic torque of knee extensors. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters. The change in muscle signaling pathways will be assessed from muscle biopsies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Sham comparator | Behavioral: Cognitive TrainingCognitive Training (riddles, skill games, ...) is performed twice a week in small groups |
| Strength Training | Experimental | Behavioral: Strength TrainingProgressive strength training is applied, meaning that the intensity is adjusted continuously in order to obtain a sufficient training stimulus. Exercises are chosen to involve the major muscle groups and are performed by using the own body weight or elastic bands. |
| Strength Training and Supplement | Experimental | Behavioral: Strength Training, Dietary Supplement: FortiFitIn addition to strength training as described above, participants receive a water-soluble dietary supplement 9x/week (FortiFit, Nutricia) consisting of 20.7 g of protein (56 En%, 19.7 g whey protein, 3 g leucine,> 10 g essential amino acids), 9.3 g carbohydrates (25 En%, 0.8 BE), 3.0 g fat (18 En%), 1.2 g fiber (2 En%), 800 IU (20μg) of vitamin D, 250mg calcium, vitamins B6 and B12, folic acid and magnesium. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State >23)
- Ability to walk 10 meters independently (without orthopaedic devices)
- 4 or more points at the Short Physical Performance Battery
Key exclusion criteria (6 listed)
- Chronic diseases, which contraindicate a medical training therapy
- Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
- Diabetic retinopathy
- Manifest osteoporosis
- Regular use of cortisone-containing drugs
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 |
|---|---|---|
| Cognitive Training | Behavioural | Cognitive Training |
| Strength Training | Behavioural | Strength Training, Strength Training and Supplement |
| FortiFit | Dietary supplement | Strength Training and Supplement |
Primary outcome
change from baseline in isokinetic torque of knee extensors
Time frame: baseline and 6 months
7 secondary outcomes
change from baseline in 6min walking test
Time frame: baseline and 6 months
change from baseline in handgrip strength
Time frame: baseline and 6 months
change from baseline in single leg balance stand
Time frame: baseline and 6 months
change from baseline in lean body mass
Time frame: baseline and 6 months
change from baseline in muscular myostatin expression
Time frame: baseline and 6 months
change from baseline in DNA strand breaks
Time frame: baseline and 6 months
change from baseline in high-sensitive C reactive protein
Time frame: baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Derived from this study: PubMed 29698742Franzke B, Schober-Halper B, Hofmann M, Oesen S, Tosevska A, Henriksen T, Poulsen HE, Strasser EM, Wessner B, Wagner KH. Age and the effect of exercise, nutrition and cognitive training on oxidative stress - The Vienna Active Aging Study (VAAS), a randomized controlled trial. Free Radic Biol Med. 2018 Jun;121:69-77. doi: 10.1016/j.freeradbiomed.2018.04.565. Epub 2018 Apr 24.
- Derived from this study: PubMed 27905522Tosevska A, Franzke B, Hofmann M, Vierheilig I, Schober-Halper B, Oesen S, Neubauer O, Wessner B, Wagner KH. Circulating cell-free DNA, telomere length and bilirubin in the Vienna Active Ageing Study: exploratory analysis of a randomized, controlled trial. Sci Rep. 2016 Dec 1;6:38084. doi: 10.1038/srep38084.
- Derived from this study: PubMed 26515246Grimpampi E, Oesen S, Halper B, Hofmann M, Wessner B, Mazza C. Reliability of gait variability assessment in older individuals during a six-minute walk test. J Biomech. 2015 Nov 26;48(15):4185-4189. doi: 10.1016/j.jbiomech.2015.10.008. Epub 2015 Oct 20.
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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.
Barbara Wessner, Ass.-Prof. DI Dr. principal investigator
University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training, Strength Training and FortiFit in people with Aging, run by University of Vienna at 1 site in Austria.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jan 2013. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Quittan, Prim. Univ.Prof. Dr. (+43160191 ext. 3401, michael.quittan@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in isokinetic torque of knee extensors (time frame: baseline and 6 months). 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 NCT01775111, 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 24 Jan 2013.