NCT02434289

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

April 22, 2015

Last Update Submit

October 7, 2015

Conditions

Sarcopenia

Keywords

Older adultsDietary proteinResistance exerciseFeasibility studyPhysical functioningReal-life setting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

Resistance exercise and protein products

EXPERIMENTAL

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 productsOther: Resistance exercise training

Interventions

Dietary protein productsDIETARY_SUPPLEMENT

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

Resistance exercise and protein products
Resistance exercise trainingOTHER

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

Resistance exercise and protein products

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • In home assisted (also informal care) elderly individuals, that experience loss of muscle strength
  • Able to understand and perform the study procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zorggroep Noordwest-Veluwe, locatie Randmeer

Harderwijk, Gelderland, 3844 DE, Netherlands

Location

Related Publications (2)

  • Tieland M, Dirks ML, van der Zwaluw N, Verdijk LB, van de Rest O, de Groot LC, van Loon LJ. Protein supplementation increases muscle mass gain during prolonged resistance-type exercise training in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):713-9. doi: 10.1016/j.jamda.2012.05.020. Epub 2012 Jul 6.

    PMID: 22770932BACKGROUND

  • van Dongen EJ, Leerlooijer JN, Steijns JM, Tieland M, de Groot LC, Haveman-Nies A. Translation of a tailored nutrition and resistance exercise intervention for elderly people to a real-life setting: adaptation process and pilot study. BMC Geriatr. 2017 Jan 18;17(1):25. doi: 10.1186/s12877-017-0413-8.

    PMID: 28100190DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lisette de Groot, Professor

    Wageningen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 5, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

NL(1)