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

Wageningen University1 site in 1 country23 target enrollmentApril 2015

ConditionsSarcopenia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sarcopenia
Sponsor: Wageningen University
Enrollment: 23
Locations: 1
Primary Endpoint: Feasibility of intervention implementation
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

September 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wageningen University

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)