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

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ClinicalTrials.gov Identifier: NCT02434289
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : October 8, 2015
Sponsor:
Collaborators:
Zorggroep Noordwest-Veluwe
FrieslandCampina
Information provided by (Responsible Party):
Wageningen University

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Dietary protein products Other: Resistance exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2015
Actual Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA) [ Time Frame: Baseline and 12 weeks ]
  2. 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 ]
  3. Change in muscle strength, as measured by a maximum strength test [ Time Frame: Baseline and 12 weeks ]
  4. Change in Quality of life, as measured by Short-Form 36 (SF-36) [ Time Frame: Baseline and 12 weeks ]
  5. Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire [ Time Frame: Baseline and 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434289


Locations
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Netherlands
Zorggroep Noordwest-Veluwe, locatie Randmeer
Harderwijk, Gelderland, Netherlands, 3844 DE
Sponsors and Collaborators
Wageningen University
Zorggroep Noordwest-Veluwe
FrieslandCampina
Investigators
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Study Director: Lisette de Groot, Professor Wageningen University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02434289    
Other Study ID Numbers: NL51834.081.14
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Keywords provided by Wageningen University:
Older adults
Dietary protein
Resistance exercise
Feasibility study
Physical functioning
Real-life setting
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms