Clinical trial NCT02434289: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Older adults
Dietary protein
Resistance exercise
Feasibility study
Physical functioning
Real-life setting
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Zorggroep Noordwest-Veluwe
name: FrieslandCampina
First posted: 2015-05-05
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Feasibility of intervention implementation
timeFrame: After 12 weeks
Secondary outcomes:
measure: Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)
timeFrame: Baseline and 12 weeks
measure: Change in physical performance, as measured by Short Physical performance Battery (SPPB), Timed Up-and-Go (TUG) and Six Minute Walking Test (6MWT)
timeFrame: Baseline and 12 weeks
measure: Change in muscle strength, as measured by a maximum strength test
timeFrame: Baseline and 12 weeks
measure: Change in Quality of life, as measured by Short-Form 36 (SF-36)
timeFrame: Baseline and 12 weeks
measure: Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Harderwijk
country: Netherlands
facility: Zorggroep Noordwest-Veluwe, locatie Randmeer
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Lisette de Groot, Professor
role: STUDY_DIRECTOR
References:
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.
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.