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

Not Applicable

Completed

• Conditions: Sarcopenia

• Registration Number: NCT02434289
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Primary Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of intervention implementation	After 12 weeks	Feasibility includes acceptability, applicability, dose received and implementation integrity. Collected in both participants and implementing health care professionals

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life, as measured by Short-Form 36 (SF-36)	Baseline and 12 weeks
Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire	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)	Baseline and 12 weeks
Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)	Baseline and 12 weeks
Change in muscle strength, as measured by a maximum strength test	Baseline and 12 weeks

Trial Locations

Locations (1)

Zorggroep Noordwest-Veluwe, locatie Randmeer; 🇳🇱 Harderwijk, Gelderland, Netherlands