Feasibility of a Resistance Exercise and Dietary Protein Intervention in Elderly People in Practice (ProMuscle 65PK)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dietary protein products
Resistance exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring Older adults, Dietary protein, Resistance exercise, Feasibility study, Physical functioning, Real-life setting
Eligibility Criteria
Inclusion Criteria:
- In home assisted (also informal care) elderly individuals, that experience loss of muscle strength
- Able to understand and perform the study procedures
Exclusion Criteria:
- 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
Sites / Locations
- Zorggroep Noordwest-Veluwe, locatie Randmeer
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resistance exercise and protein products
Arm Description
Practice intervention trial including resistance exercise training and intake of dietary protein products in (frail) elderly, implemented by health care professionals.
Outcomes
Primary Outcome Measures
Feasibility of intervention implementation
Feasibility includes acceptability, applicability, dose received and implementation integrity. Collected in both participants and implementing health care professionals
Secondary Outcome Measures
Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)
Change in physical performance, as measured by Short Physical performance Battery (SPPB), Timed Up-and-Go (TUG) and Six Minute Walking Test (6MWT)
Change in muscle strength, as measured by a maximum strength test
Change in Quality of life, as measured by Short-Form 36 (SF-36)
Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire
Full Information
NCT ID
NCT02434289
First Posted
April 22, 2015
Last Updated
October 7, 2015
Sponsor
Wageningen University
Collaborators
Zorggroep Noordwest-Veluwe, FrieslandCampina
1. Study Identification
Unique Protocol Identification Number
NCT02434289
Brief Title
Feasibility of a Resistance Exercise and Dietary Protein Intervention in Elderly People in Practice (ProMuscle 65PK)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
Collaborators
Zorggroep Noordwest-Veluwe, FrieslandCampina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Older adults, Dietary protein, Resistance exercise, Feasibility study, Physical functioning, Real-life setting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance exercise and protein products
Arm Type
Experimental
Arm Description
Practice intervention trial including resistance exercise training and intake of dietary protein products in (frail) elderly, implemented by health care professionals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary protein products
Intervention Description
Increased protein intake via dairy products, guided by a dietician.
Intervention Type
Other
Intervention Name(s)
Resistance exercise training
Intervention Description
Resistance exercise training in small groups for twelve weeks, two times a week, guided by physiotherapists.
Primary Outcome Measure Information:
Title
Feasibility of intervention implementation
Description
Feasibility includes acceptability, applicability, dose received and implementation integrity. Collected in both participants and implementing health care professionals
Time Frame
After 12 weeks
Secondary Outcome Measure Information:
Title
Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)
Time Frame
Baseline and 12 weeks
Title
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
Title
Change in muscle strength, as measured by a maximum strength test
Time Frame
Baseline and 12 weeks
Title
Change in Quality of life, as measured by Short-Form 36 (SF-36)
Time Frame
Baseline and 12 weeks
Title
Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In home assisted (also informal care) elderly individuals, that experience loss of muscle strength
Able to understand and perform the study procedures
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette de Groot, Professor
Organizational Affiliation
Wageningen University
Official's Role
Study Director
Facility Information:
Facility Name
Zorggroep Noordwest-Veluwe, locatie Randmeer
City
Harderwijk
State/Province
Gelderland
ZIP/Postal Code
3844 DE
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22770932
Citation
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.
Results Reference
background
PubMed Identifier
28100190
Citation
van 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.
Results Reference
derived
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Feasibility of a Resistance Exercise and Dietary Protein Intervention in Elderly People in Practice (ProMuscle 65PK)
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