SarcopeniaNCT02434289
Feasibility of a Resistance Exercise and Dietary Protein Intervention in Elderly People in Practice (ProMuscle 65PK)
A study testing Dietary protein products and Resistance exercise training in people with Sarcopenia, run by Wageningen University at 1 site in Netherlands.
Trial summary
The purpose of this pilot study is to investigate the feasibility and potential impact of a combined resistance exercise and increased protein intake intervention in (frail) elderly, in a real-life setting. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Dietary protein products and Resistance exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2015to Sep 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- In home assisted (also informal care) elderly individuals, that experience loss of muscle strength
- Able to understand and perform the study procedures
Who cannot join
- Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol) or hypertension, unless well regulated by medication
- Diagnosed cancer or Chronic Obstructive Pulmonary Disease (COPD)
- Severe heart failure
- Renal insufficiency (eGFR <60 mL/min/1.73 m2)
- Newly placed hip/knee prosthesis (unless fully recovered), or recent surgery (stress on scar tissue)
- Allergic or sensitive for milk proteins
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Zorggroep Noordwest-Veluwe, locatie Randmeer
Harderwijk, Gelderland, 3844 DE
About this study
Official title: Pilot Study to Study the Feasibility and Potential Impact of a Combined Resistance Exercise and Increased Protein Intake Intervention in (Frail) Elderly People, in a Real-life Setting
The purpose of this pilot study is to investigate the feasibility and potential impact of a combined resistance exercise and increased protein intake intervention in (frail) elderly, in a real-life setting.
- Conditions
- Sarcopenia
- Being tested
- Dietary protein products, Resistance exercise training
- Keywords
- Older adults, Dietary protein, Resistance exercise, Feasibility study, Physical functioning, Real-life setting
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary protein productsDietary supplement
Increased protein intake via dairy products, guided by a dietician.
Resistance exercise trainingOther
Resistance exercise training in small groups for twelve weeks, two times a week, guided by physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise and protein products | Experimental | Practice intervention trial including resistance exercise training and intake of dietary protein products in (frail) elderly, implemented by health care professionals. Receives: Dietary Supplement: Dietary protein products; Other: Resistance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention implementation
Feasibility includes acceptability, applicability, dose received and implementation integrity. Collected in both participants and implementing health care professionals
Measured: After 12 weeks
Secondary outcomes (5)
Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)
Measured: Baseline and 12 weeks
Change in physical performance, as measured by Short Physical performance Battery (SPPB), Timed Up-and-Go (TUG) and Six Minute Walking Test (6MWT)
Measured: Baseline and 12 weeks
Change in muscle strength, as measured by a maximum strength test
Measured: Baseline and 12 weeks
Change in Quality of life, as measured by Short-Form 36 (SF-36)
Measured: Baseline and 12 weeks
Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Zorggroep Noordwest-Veluwe, FrieslandCampina
- Responsible party
- Sponsor
- Investigators
- Lisette de Groot, Professor, Study director, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434289
- Sponsor's protocol ID
- NL51834.081.14
- Status last verified
- Oct 2015
- First submitted
- 22 Apr 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tieland M, Dirks ML, van der Zwaluw N, Verdijk LB, van de Rest O, de Groot LC, van Loon LJ. Protein supplementation increases muscle mass gain during prolonged resistance-type exercise training in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):713-9. doi: 10.1016/j.jamda.2012.05.020. Epub 2012 Jul 6.
PubMed 22770932van Dongen EJ, Leerlooijer JN, Steijns JM, Tieland M, de Groot LC, Haveman-Nies A. Translation of a tailored nutrition and resistance exercise intervention for elderly people to a real-life setting: adaptation process and pilot study. BMC Geriatr. 2017 Jan 18;17(1):25. doi: 10.1186/s12877-017-0413-8.
PubMed 28100190
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Study the Feasibility and Potential Impact of a Combined Resistance Exercise and Increased Protein Intake Intervention in (Frail) Elderly People, in a Real-life Setting
- ClinicalTrials.gov ID
- NCT02434289
- Acronym / sponsor ID
- NL51834.081.14
- Conditions
- Sarcopenia
- Keywords
- Older adults, Dietary protein, Resistance exercise, Feasibility study, Physical functioning, Real-life setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Zorggroep Noordwest-Veluwe, FrieslandCampina
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- First posted
- 5 May 2015 (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 pilot study is to investigate the feasibility and potential impact of a combined resistance exercise and increased protein intake intervention in (frail) elderly, in a real-life setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise and protein products | Experimental | Dietary Supplement: Dietary protein products, Other: Resistance exercise trainingPractice intervention trial including resistance exercise training and intake of dietary protein products in (frail) elderly, implemented by health care professionals. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- In home assisted (also informal care) elderly individuals, that experience loss of muscle strength
- Able to understand and perform the study procedures
Key exclusion criteria (6 listed)
- Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol) or hypertension, unless well regulated by medication
- Diagnosed cancer or Chronic Obstructive Pulmonary Disease (COPD)
- Severe heart failure
- Renal insufficiency (eGFR <60 mL/min/1.73 m2)
- Newly placed hip/knee prosthesis (unless fully recovered), or recent surgery (stress on scar tissue)
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 |
|---|---|---|
| Dietary protein productsIncreased protein intake via dairy products, guided by a dietician. | Dietary supplement | Resistance exercise and protein products |
| Resistance exercise trainingResistance exercise training in small groups for twelve weeks, two times a week, guided by physiotherapists. | Other | Resistance exercise and protein products |
Primary outcome
Feasibility of intervention implementation
Time frame: After 12 weeks
Feasibility includes acceptability, applicability, dose received and implementation integrity. Collected in both participants and implementing health care professionals
5 secondary outcomes
Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)
Time frame: Baseline and 12 weeks
Change in physical performance, as measured by Short Physical performance Battery (SPPB), Timed Up-and-Go (TUG) and Six Minute Walking Test (6MWT)
Time frame: Baseline and 12 weeks
Change in muscle strength, as measured by a maximum strength test
Time frame: Baseline and 12 weeks
Change in Quality of life, as measured by Short-Form 36 (SF-36)
Time frame: Baseline and 12 weeks
Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire
Time frame: Baseline and 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 8 Oct 2015.
- Background: PubMed 22770932Tieland M, Dirks ML, van der Zwaluw N, Verdijk LB, van de Rest O, de Groot LC, van Loon LJ. Protein supplementation increases muscle mass gain during prolonged resistance-type exercise training in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):713-9. doi: 10.1016/j.jamda.2012.05.020. Epub 2012 Jul 6.
- Derived from this study: PubMed 28100190van Dongen EJ, Leerlooijer JN, Steijns JM, Tieland M, de Groot LC, Haveman-Nies A. Translation of a tailored nutrition and resistance exercise intervention for elderly people to a real-life setting: adaptation process and pilot study. BMC Geriatr. 2017 Jan 18;17(1):25. doi: 10.1186/s12877-017-0413-8.
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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.
Lisette de Groot, Professor study director
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary protein products and Resistance exercise training in people with Sarcopenia, run by Wageningen University at 1 site in Netherlands.
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 2 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: finished, as of the sponsor's last update on 8 Oct 2015. 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 Netherlands. 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?
Feasibility of intervention implementation (time frame: After 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 NCT02434289, which also lists 2 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 8 Oct 2015.