Feasibility of a Resistance Exercise and Dietary Protein Intervention in Elderly People in Practice (ProMuscle 65PK)

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434289
• Other study ID #: NL51834.081.14
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: October 7, 2015
• Start date: April 2015

Study information

• Verified date: October 2015
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Dietary protein products
Increased protein intake via dairy products, guided by a dietician.

Other:
• Resistance exercise training
Resistance exercise training in small groups for twelve weeks, two times a week, guided by physiotherapists.

Locations

Country	Name	City	State
Netherlands	Zorggroep Noordwest-Veluwe, locatie Randmeer	Harderwijk	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	FrieslandCampina, Zorggroep Noordwest-Veluwe

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of intervention implementation	Feasibility includes acceptability, applicability, dose received and implementation integrity. Collected in both participants and implementing health care professionals	After 12 weeks	No
Secondary	Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)		Baseline and 12 weeks	No
Secondary	Change in physical performance, as measured by Short Physical performance Battery (SPPB), Timed Up-and-Go (TUG) and Six Minute Walking Test (6MWT)		Baseline and 12 weeks	No
Secondary	Change in muscle strength, as measured by a maximum strength test		Baseline and 12 weeks	No
Secondary	Change in Quality of life, as measured by Short-Form 36 (SF-36)		Baseline and 12 weeks	No
Secondary	Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire		Baseline and 12 weeks	No