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

Sarcopenia Clinical Trial

— PEPOP  

Official title:

A Protein-enriched, Milk-based Supplement to Counteract Sarcopenia in Acutely Ill Geriatric Patients Offered Resistance Exercise Training During and After Hospitalisation - a Double-blinded, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717819
• Other study ID #: EFFECT.PEPOP.2016
• Secondary ID: H-16018240
• Status: Completed
• Phase: N/A
• Start date: April 15, 2016
• Est. completion date: June 20, 2018

Study information

• Verified date: August 2018
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: June 20, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Protein
Daily intake of supplement
• Placebo
Daily intake of supplement

Other:
• Resistance training
Resistance training (offered daily while hospitalized, and encouragement of 4 x/week as self-training after discharge)

Dietary Supplement:
• Vitamin D
Aiming at a dose of 20 ug/day. 20 ug/day will be handed out to study participants who do not get vitamin D supplements from the hospital while admitted and to those who are not already taking vitamin D supplements themselfes e.g. as part of a combination tablet.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Gentofte	Gentofte
Denmark	Rigshospitalet-Glostrup	Glostrup
Denmark	Copenhagen University Hospital Herlev	Herlev

Sponsors (6)

Lead Sponsor	Collaborator
Forskningsenheden	Arla Foods, Glostrup University Hospital, Copenhagen, The Danish Dairy Research Foundation, Denmark, University Hospital, Gentofte, Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lean body mass (sub group n=30)	Lean body mass (total, appendicular, and trunk) evaluated by whole-body dual energy x-ray absorptiometry (DXA)-scanning.	Baseline (while admitted to hospital) and 12 weeks post discharge
Other	Fat mass (sub group n=30)	Total mass. Evaluated by whole-body dual energy x-ray absorptiometry (DXA)-scanning and bio-impedance analysis (BIA).	Baseline (while admitted to hospital) and 12 weeks post discharge
Other	Reliability of bio-impedance analyzer in sub-group (n=30)	Degree of agreement between two subsequent measurements.	Baseline (while admitted to hospital)
Other	Prevalence of sarcopenia	According to the EWGSOP definition (yes/no).	Baseline (while admitted to hospital)
Other	Classification of sarcopenia	According to the EWGSOP definition (pre-sarcopenia, sarcopenia, and severe sarcopenia).	Baseline (while admitted to hospital)
Other	Nutritional status - Body mass index (BMI)	According to BMI (kg/m2) (< 18.5, 18.5-20.5, 20.5-25, > 25)	Baseline (while admitted to hospital)
Other	Nutritional status - Mini Nutritional Assessment (MNA)	According to Mini Nutritional Assessment (MNA) (no malnutrition, risk of malnutrition, malnutrition).	Baseline (while admitted to hospital)
Other	Nutritional status - Malnutrition Universal Screening Tool (MUST)	According to Malnutrition Universal Screening Tool (MUST) (low risk of MN, medium risk of MN, high risk of MN)	Baseline (while admitted to hospital)
Other	Nutritional status - Nutritional Risk Screening 2002 (NRS-2002)	According to Nutritional Risk Screening 2002 (NRS-2002) (no MN, mild MN, moderate MN, severe MN).	Baseline (while admitted to hospital)
Other	Energy intake	Daily registration schemes with pre-printed hospital foods and drinks (energy, kJ/kg).	4 days while admitted to hospital, or shorter if discharged
Other	Protein intake	Daily registration schemes with pre-printed hospital foods and drinks (protein, g/kg).	4 days while admitted to hospital, or shorter if discharged
Other	Energy intake	Dietary interviews x 4 (24-h recall interviews) (energy, kJ/kg).	From discharge until 12 weeks post discharge
Other	Protein intake	Dietary interviews x 4 (24-h recall interviews) (protein, g/kg).	From discharge until 12 weeks post discharge
Other	Level of daily activity	Activity interviews x 4 (recall interviews for the previous week)	From discharge until 12 weeks post discharge
Primary	Change in 30-s chair stand performance	Number of stand-ups from a chair in 30 seconds (modified version, help from armrests are allowed).	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Total lean body mass	Lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Appendicular lean body mass	Appendicular lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Trunk lean body mass	Trunk lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Change in hand grip strength	Isometric hand grip strength (kg) (Saehan Medical digital dynamometer, 2012).	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Change in 4 m gait speed	The time used for walking 4 m (m/s and s )	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Change in Activities of daily living (ADL)	Use of Barthel-100	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Change in mobility	Use of De Morton Mobility Index (DEMMI)	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Change in cognitive functioning	Use of Mini Mental State Examination (MMSE)	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Use of home care	Interview: (yes/no)	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Residence	Interview: (own home, nursing home/assisted living facility, 24-hour rehabilitation facility)	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Use of gait aid	Interview: yes/no/cannot walk and registration of specific gait help	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Length of hospital stay (LOS)	The in-hospital intervention period (date of recruitment until date of discharge) (days)	Day of discharge (from hospital)
Secondary	Readmission to hospital	Frequency (number)	From discharge until 12 weeks post discharge, and 6 months post discharge
Secondary	Length of total hospital stay for readmissions	Total length (days).	From discharge until 12 weeks post discharge, and 6 months post discharge
Secondary	Mortality	Mortality (yes/no)	From discharge until 12 weeks post discharge, and 6 months post discharge
Secondary	Change in health related Quality of life	Questionnaire: Euroqol EQ-5D-3L	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Change in Body weight	Measured to the nearest 0.1 kg using a calibrated scale	Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary	Study population acceptance of product	Self-administered evaluation-questionnaire	12 weeks post discharge