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Completed

NCT Number: NCT02434289

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zorggroep Noordwest-Veluwe, locatie Randmeer

Harderwijk, Gelderland, 3844 DE, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary protein products

Dietary Supplement

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

Resistance Exercise Training

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • FrieslandCampina
  • Zorggroep Noordwest-Veluwe

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
First posted
May 5, 2015
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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