The Importance of Additional Protein to Benefit More From Training During and After Hospitalization (PEPOP)

Forskningsenheden

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Protein; Dietary Supplement: Vitamin D; Other: Resistance training

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02717819

H-16018240 (Other Identifier)

EFFECT.PEPOP.2016

Details and patient eligibility

About

The purpose of the study is to investigate if an increased protein intake, in the form of a protein-enriched, milk-based supplement, can enhance the beneficial effect of resistance training, offered during hospitalization and 12 weeks post discharge, in older patients. This will in part be evaluated from measures of muscle strength, muscle mass and physical functioning. Also, the study population's acceptance of the intervention product will be assessed along with measures related to 'cost-effectiveness'.

A sub-study will be performed in a sub-group (n=30) to investigate if bio-impedance analysis (BIA) correlates with Dual-Energy X-ray absorptiometry (DXA) at single time points, and to see if it is possible to track changes in lean body mass. In addition, the reliability of the bio-impedance analyzer will be evaluated.

Also, the prevalence and classification of sarcopenia will be assessed at baseline, and correlations to nutritional status will be investigated (n=120).

Full description

Main study:

The study design is a block randomised, double-blind, placebo-controlled, multicentre intervention study. A total of 120 hospitalized older adults, above 70 years, will be recruited consecutively from the medical departments of three Hospitals in the Capital Region of Denmark (n=40 each place).

Participants will be randomized into two groups - one group receives protein-enriched, milk-based supplements and the other group receives iso-energetic placebo products. Both groups participate in the same standardized resistance training program, and will be blinded to the supplement content. One training session consists of three exercises of the lower extremities (3 sets of 10 repetitions, pursuing an intensity of 8-12 repetition maximum (RM)). While admitted, supervised resistance training is offered daily. After discharge, the participants are encouraged to perform the same program as self-training four times per week.To ensure progression (or regression if necessary) the participants receive follow-up home visits by a physiotherapist, and thus after discharge the participants are closely monitored. All participants, irrespective of allocation, will get a daily vitamin D supplement.

The study duration for each participant starts while admitted to hospital and lasts until 12 weeks after discharge. Endpoint assessments will be performed at baseline (> 72-h after admission to hospital), after discharge (> 72-h) and 12 weeks (± 2 days) after discharge. A few endpoints will be collected during follow-up (6 months post intervention). Data will be collected by study investigators blinded to the allocation of the participants.

Sub-study: 'Validation of a portable bio-impedance analyzer in a population of older adults ≥ 70 years for the assessment of muscle mass and changes in muscle mass over time' A sub-study will be performed to investigate if the portable InBody-230 BIA correlate with DXA at single time points in 30 hospitalized older people ≥ 70 years, and to see if it is possible to track changes in LBM during the 12-week intervention. Total LBM, total fat mass, and percent LBM will be measured and compared as well as appendicular and trunk LBM. In addition, the reliability of the portable bio-impedance analyzer will be evaluated by assessing the degree of agreement between two subsequent measurements. In continuation of recruitment to the primary study, a subset of participants (n=30) will be asked if they want to participate in this sub-study, irrespective of their allocation in the main study. The measurements are going to be performed twice, while hospitalized and 12 weeks after discharge (± 5 days).

Sub-study: 'Prevalence of sarcopenia and investigation of the relationship between nutritional status and the EWGSOP conceptual stages for sarcopenia in hospitalized older patients > 70 years'.

The prevalence and classification of sarcopenia among Danish hospitalized older patients ≥ 70 years old (n=120) will be evaluated, according to the EWGSOP definition (Hand-grip-strength, 4-m gait speed, Bio-Impedance analysis). Also, examination of the relationship between measurements of nutritional status and the EWGSOP stages for sarcopenia (i.e. no sarcopenia, pre-sarcopenia, sarcopenia and severe sarcopenia) will be assessed at baseline. Nutritional status will be assessed according to BMI (< 18.5, 18.5-20.5, 20.5-25, > 25), Mini Nutritional Assessment (MNA) (no MN, risk of MN, MN), Malnutrition Universal Screening Tool (MUST) (low risk of MN, medium risk of MN, high risk of MN), and NRS-2002 (no MN, mild MN, moderate MN, severe MN)

Results will be communicated to the general population and published in peer-reviewed journals.

Enrollment: 165 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women aged ≥ 70 years old
• Able to speak and understand Danish
• Expected length of stay > 3 days (evaluated by medical staff at department)
• Ability to stand independently without walking aids
• Admitted to the medical departments of Gentofte or Herlev Hospital or Rigshospitalet-Glostrup

Exclusion criteria

• Active cancer
• Renal insufficiency (eGFR < 30 mL/min/1.73m2)
• Cognitive impairment (not able to comprehend the purpose of the study/give informed consent)
• Terminal disease
• Exclusively receiving enteral or parenteral nutrition
• Milk/lactose allergy or intolerance
• Planning to lose weight/go on a special diet
• Planned transfer to other hospitals/departments
• Pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis (BIA) measurements)
• Not being able to lie still in seven minutes (only an exclusion criteria in the sub-study)
• Withdrawal criteria: Death during admission (does not apply to subsequent admissions)
• Withdrawal criteria: Discharge/transfer from the medical department before the intervention has started

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 2 patient groups, including a placebo group

Resistance training and protein

Experimental group

Description:

Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x 125 ml protein-enriched, milk-based supplements (whey protein), in the same period (additional \~25 g protein and 1953 kJ per day). Daily vitamin D supplements.

Treatment:

Other: Resistance training

Dietary Supplement: Protein

Dietary Supplement: Vitamin D

Resistance training and placebo

Placebo Comparator group

Description:

Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x125 ml iso-energetic placebo-supplements, in the same period. Daily vitamin D supplements.

Treatment:

Other: Resistance training

Dietary Supplement: Placebo

Dietary Supplement: Vitamin D