Physical ActivityNCT03120143
Small-sided Ball Game Training and Protein Intake in Older Adults
A study testing Small-sided ball game training with high protein intake and Small-sided ball game training with low protein intake in people with Physical Activity, run by University of Copenhagen.
Trial summary
The effect of small-sided team sport training and protein intake on muscle mass, physical function, and adaptations important for health in untrained older adults was examined. Forty-eight untrained older (72±6 years) men and women were divided into either a team sport group ingesting a drink high in protein (18 g)… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Small-sided ball game training with high protein intake and Small-sided ball game training with low protein intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2016
- 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
- adults aged 65 years or older
Who cannot join
- severe cardiovascular or neurological disease and participation in regular intense exercise training or sports
About this study
Official title: Effect of Small-sided Team Sport Training and Protein Intake on Muscle Mass, Physical Function and Markers of Health in Older Untrained Adults
The effect of small-sided team sport training and protein intake on muscle mass, physical function, and adaptations important for health in untrained older adults was examined. Forty-eight untrained older (72±6 years) men and women were divided into either a team sport group ingesting a drink high in protein (18 g) immediately and 3 h after each training session (TS-HP, n=13), a team sport group ingesting an isocaloric drink with low protein content (3 g; TS-LP, n=18), and a control group continuing their normal activities (CON, n=17).
- Conditions
- Physical Activity
- Being tested
- Small-sided ball game training with high protein intake, Small-sided ball game training with low protein intake
- Keywords
- Small-sided ball games, Aging, Muscle mass, Health, Training, Protein intake, Physical function, Physiological adaptations
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small-sided ball game training with high protein intakeOther
In the present study, small-sided ball game training consists of repeated intervals of floorball and cone ball training on small areas and 3-4 participants on each team. The supplementation high in protein consists of 18 g protein consumed immediately after and 3 h post exercise
Small-sided ball game training with low protein intakeOther
n the present study, small-sided ball game training consists of repeated intervals of floorball and cone ball training on small areas and 3-4 participants on each team. The supplementation low in protein consists of 3 g protein consumed immediately after and 3 h post exercise.
| Study group | Role | What they receive |
|---|---|---|
| Team sport and high protein group | Experimental | This group participated in team sport based small-sided ball games with supplementation of a drink with a high content of protein after the training sessions Receives: Other: Small-sided ball game training with high protein intake |
| Team sport and low protein group | Experimental | This group participated in team sport based small-sided ball games with supplementation of a drink low in protein content after the training sessions Receives: Other: Small-sided ball game training with low protein intake |
| Control group | No intervention | This group continued their usual life style without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Lean body mass in kg determined by DXA scanning
Measured: 12 weeks
Secondary outcomes (1)
Physical function
Sit to stand performance (repetitions in 30 s)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
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 Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Municipality, Denmark, Nestlé Institute of Health Sciences
- Responsible party
- Principal investigator, Jacob Vorup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120143
- Sponsor's protocol ID
- H-15002409
- Status last verified
- Oct 2017
- First submitted
- 10 Apr 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vorup J, Pedersen MT, Brahe LK, Melcher PS, Alstrom JM, Bangsbo J. Effect of small-sided team sport training and protein intake on muscle mass, physical function and markers of health in older untrained adults: A randomized trial. PLoS One. 2017 Oct 10;12(10):e0186202. doi: 10.1371/journal.pone.0186202. eCollection 2017.
PubMed 29016675
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Small-sided Team Sport Training and Protein Intake on Muscle Mass, Physical Function and Markers of Health in Older Untrained Adults
- ClinicalTrials.gov ID
- NCT03120143
- Acronym / sponsor ID
- H-15002409
- Conditions
- Physical Activity
- Keywords
- Small-sided ball games, Aging, Muscle mass, Health, Training, Protein intake, Physical function, Physiological adaptations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen Municipality, Denmark, Nestlé Institute of Health Sciences
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Apr 2017 (actual)
- 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 effect of small-sided team sport training and protein intake on muscle mass, physical function, and adaptations important for health in untrained older adults was examined. Forty-eight untrained older (72±6 years) men and women were divided into either a team sport group ingesting a drink high in protein (18 g) immediately and 3 h after each training session (TS-HP, n=13), a team sport group ingesting an isocaloric drink with low protein content (3 g; TS-LP, n=18), and a control group continuing their normal activities (CON, n=17).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Team sport and high protein group | Experimental | Other: Small-sided ball game training with high protein intakeThis group participated in team sport based small-sided ball games with supplementation of a drink with a high content of protein after the training sessions |
| Team sport and low protein group | Experimental | Other: Small-sided ball game training with low protein intakeThis group participated in team sport based small-sided ball games with supplementation of a drink low in protein content after the training sessions |
| Control group | No intervention | –This group continued their usual life style without intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- adults aged 65 years or older
Key exclusion criteria (1 listed)
- severe cardiovascular or neurological disease and participation in regular intense exercise training or sports
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 |
|---|---|---|
| Small-sided ball game training with high protein intakeIn the present study, small-sided ball game training consists of repeated intervals of floorball and cone ball training on small areas and 3-4 participants on each team. The supplementation high in protein consists of 18 g protein consumed immediately after and 3 h post exercise | Other | Team sport and high protein group |
| Small-sided ball game training with low protein intaken the present study, small-sided ball game training consists of repeated intervals of floorball and cone ball training on small areas and 3-4 participants on each team. The supplementation low in protein consists of 3 g protein consumed immediately after and 3 h post exercise. | Other | Team sport and low protein group |
Primary outcome
Muscle mass
Time frame: 12 weeks
Lean body mass in kg determined by DXA scanning
1 secondary outcome
Physical function
Time frame: 12 weeks
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 27 Oct 2017.
- Derived from this study: PubMed 29016675Vorup J, Pedersen MT, Brahe LK, Melcher PS, Alstrom JM, Bangsbo J. Effect of small-sided team sport training and protein intake on muscle mass, physical function and markers of health in older untrained adults: A randomized trial. PLoS One. 2017 Oct 10;12(10):e0186202. doi: 10.1371/journal.pone.0186202. eCollection 2017.
Related trials for Physical Activity
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Small-sided ball game training with high protein intake and Small-sided ball game training with low protein intake in people with Physical Activity, run by University of Copenhagen.
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 1 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Muscle mass (time frame: 12 weeks). 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 NCT03120143, 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 27 Oct 2017.