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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Dietary protein products
* Other: Resistance exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance exercise and protein products<br>Practice intervention trial including resistance exercise training and intake of dietary protein products in (frail) elderly, implemented by health care professionals. | Dietary Supplement: Dietary protein products<br>* Increased protein intake via dairy products, guided by a dietician.<br>Other: Resistance exercise training<br>* Resistance exercise training in small groups for twelve weeks, two times a week, guided by physiotherapists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA) |  | 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 muscle strength, as measured by a maximum strength test |  | Baseline and 12 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Dietary protein, Resistance exercise, Feasibility study, Physical functioning, Real-life setting