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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02434289

Enrollment

Registered

2015-05-05

Start date

2015-04-30

Completion date

Unknown

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Older adults, Dietary protein, Resistance exercise, Feasibility study, Physical functioning, Real-life setting

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.

Interventions

DIETARY_SUPPLEMENTDietary protein products

Increased protein intake via dairy products, guided by a dietician.

OTHERResistance exercise training

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire	Baseline and 12 weeks
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026