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

October 7, 2015 updated by: Wageningen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Harderwijk, Gelderland, Netherlands, 3844 DE
        • Zorggroep Noordwest-Veluwe, locatie Randmeer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance exercise and protein products
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

FrieslandCampina
Zorggroep Noordwest-Veluwe

Investigators

  • Study Director: Lisette de Groot, Professor, Wageningen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL51834.081.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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