Individualized Physical Exercise Training and Enhanced Protein Intake in Older Citizens During Municipality-based Rehabilitation

The study will investigate if: 1) individualized physical exercise training in combination with extra protein intake can increase measures on all three ICF-levels? 2) extra protein intake alone increases outcomes of usual care treatment?

Study Overview

• Status: Completed
• Conditions: Rehabilitation
• Intervention / Treatment: Other: Usual Care; Other: Usual Care with Protein Supplementation; Other: Individualized Physical Exercise Training with Protein Supplementation

Detailed Description

Successful rehabilitation of the growing number of elderly citizens can lead to preservation of functional independence and improvement in the quality of life.

The aim of the study is to investigate the effect of an individually tailored physical exercise training program combined with increased protein intake in order to improve measures on all three ICF levels (International Classification of Functioning, Disability, and Health). By conducting the study in a real-life clinical setting, research is translated into practice involving health professionals and the target group in the development of new knowledge on how to enhance the outcome of rehabilitation, thereby increasing the overall capacity of the elderly citizen, and decreasing the expenditure of health-services.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Zealand
    • Slagelse, Zealand, Denmark, 4200
      • Sundhed og Træning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All citizens that are referred to the health/rehabilitation center age 65 years and older from Slagelse municipality will be invited to a screening interview with a physiotherapist after which the participant will be asked to join the study if not subject to one of the following exclusion criteria's:

Exclusion Criteria:

• inability to speak or read Danish,
• renal diseases,
• active cancer,
• upper or lower limp amputations,
• milk/lactose allergy or intolerance,
• hypertension >180/110,
• pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis),
• progressive somatic or psychiatric diseases which can affect the course of training,
• referred to rehabilitation primarily due to gynecological and neurological conditions (apoplexies) or surgeries where movement restrictions are recommended,
• daily medication that may have an impact on muscle protein synthesis,
• alcohol intake greater than 14 units per week,
• discouragement from a general practitioner.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.	Other: Usual Care; Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.
Experimental: Usual Care with Protein Supl.; Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.	Other: Usual Care with Protein Supplementation; The intake of protein supplementation (ARLA PROTINO) will be consumed by participants in the form of protein-enriched yogurts for easy consumption two times daily, with each bottle containing 14 g of protein.; Other Names: ARLA PROTINO
Experimental: Individualized Physical Exercise Training with Protein Supl.; This group is also called EXER group, and will receive individually tailored physical exercise programs, based on their strength and weaknesses from the baseline testing.	Other: Individualized Physical Exercise Training with Protein Supplementation; Besides getting prescribed individualized physical exercise training programs, this group will consume protein supplementation (ARLA PROTINO) in form of protein enriched yogurts for easy consumption, two times daily, with each bottle containing 14 g of protein.; Other Names: ARLA PROTINO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Musculoskeletal Function Assessment (SMFA) - Dysfunction Index	Self reported	Change from: baseline to 3 months (primary endpoint) and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in mobility with The New Mobility Score	The New Mobility Score assesses the patient's walking function inside, outside, and during shopping. Including whether a walking aid is used. The NMS provides a composed score of the participants' mobility. Each question is scored between 0-3 points, depending on the degree of help. The total possible score is between 0 and 9 points.	Change from: baseline to 3 months and 12 months
Mean change from baseline in the PRISMA-7 score	The PRISMA-7 questionnaire is composed of seven items and is used to indicate frailty among participants - each question scores either 0 or 1 points. The total possible score is between 0 and 7 points.	Change from: baseline to 3 months and 12 months
Mean change from baseline in the Tilburg Frailty Scale score	The Tilburg Frailty Scale is a questionnaire with a bio-psycho-social approach, which measures frailty. It is composed of 15 multidimensional questions, regarding the physical, psychological, and social aspects of human functioning. Scoring range is between 0-15 points.	Change from: baseline to 3 months and 12 months
Mean change from baseline in health-related quality of life on SF-36	The SF-36 is a generic questionnaire that measures health-related quality of life in the past four weeks. The questionnaire consists of 36 questions which are divided into eight sub-scales and summarized in 2 sum scores.	Change from: baseline to 3 months and 12 months
Measure of pain, physical activity level and educational level	A survey with self-formulated questions regarding name, sex, personal ID (CPR number), educational level, the region of pain the last three months (marked on a body chart), pain intensity at the site of pain, and physical activity level will also be collected.	Change from: baseline to 3 months and 12 months
Mean change from baseline in weight	Weight (in kilograms). Weight and height will be combined to report BMI in kg/m^2.	Change from: baseline to 3 months and 12 months
Measure of height at baseline	Height (in meters). Weight and height will be combined to report BMI in kg/m^2.	Baseline
Mean change from baseline in blood pressure	Systolic and diastolic blood pressure (mmHg) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.	Change from: baseline to 3 months and 12 months
Mean change from baseline in resting heart rate	Resting heart rate (in beats per minute) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.	Change from: baseline to 3 months and 12 months
Mean change from baseline in body composition measured with a bioimpedance device	The electrical bioimpedance device used in the present study to measure changes in body composition is the "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyzer". Lean body mass (in kilograms), fat percentage (described as a percentage of the total body mass), total body water (described as a percentage of the total body mass), a visceral fat indicator will be reported	Change from: baseline to 3 months and 12 months
Mean change from baseline in the basic metabolic rate (BMR)	BMR will be estimated by a bioelectrical impedance analysis device "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyze".	Change from: baseline to 3 months and 12 months
Mean change from baseline of Waist-To-Hip ratio	The circumference of the waist (in centimeters) will be divided with the circumference of the hip (in centimeters) to report the Waist-to-hip ratio.	Change from: baseline to 3 months and 12 months
Mean change from baseline in maximal isometric voluntary contraction of leg extension	A maximal isometric voluntary contraction (in newtons) for knee extension will be performed using a strain gauge.	Change from: baseline to 3 months and 12 months
Mean change from baseline in handgrip strength	The handgrip strength (in kilograms) will be measured using a hydraulic handgrip dynamometer (SAEHAN).	Change from: baseline to 3 months and 12 months
Mean change from baseline in leg press strength	Five repetitions maximum (RM) strength tests will be performed in the leg press (in kilograms) to calculate 1 RM.	Change from: baseline to 3 months and 12 months
Mean change from baseline in knee extension strength	Five repetitions maximum (RM) strength tests will be performed in knee extension (in kilograms) to calculate 1 RM.	Change from: baseline to 3 months and 12 months
Mean change from baseline in calf extension strength	Five repetitions maximum (RM) strength tests will be performed in the calf extension (in kilograms) to calculate 1 RM.	Change from: baseline to 3 months and 12 months
Mean change from baseline in function measured with the 2 minutes walk test (2MWT)	The 2MWT will measure the distance (in meters) a person can walk in 2 minutes. Gaits speed will be calculated by dividing the covered distance with the time (120 seconds).	Change from: baseline to 3 months and 12 months
Mean change from baseline in heart rate during 2 minutes walk test (2MWT)	Heart rate (in BPM) will be measured (using the Apple Watch serie 5) before and right after the 2MWT.	Change from: baseline to 3 months and 12 months
Mean change from baseline in heart rate before and after the 2 minutes walk test (2MWT)	Heart rate (in BPM) will be measured (using the Apple Watch serie 5) before and right after the 2MWT.	Change from: baseline to 3 months and 12 months
Mean change from baseline in The Borg Rating of Perceived Exertion before and after the 2 minutes walk test (2MWT)	The Borg Rating of Perceived Exertion will be used to estimate the activity intensity before and right after the 2MWT.	Change from: baseline to 3 months and 12 months
Mean change from baseline in function measured with the Timed Up and Go test (TUG)	Time is noted (in seconds) on how long it takes to get up from a chair, walk 3 meters, turn around and go back to the chair and sit down again.	Change from: baseline to 3 months and 12 months
Mean change from baseline in balance measured with the Tandem test	A measure of static balance will be performed using a Tandem test. The participants will be tested in three positions for 10 seconds each (feet together, semi tandem and full tandem). Time is noted (in seconds) for how long the participant can stand in each position.	Change from: baseline to 3 months and 12 months
Balance and reaction time for upper and lower extremity	Measures for balance and reaction time will be collected using the "Fysiometer," and the protocols within the "Fysiometer" software will be followed.	Change from: baseline to 3 months and 12 months
Protein and energy intake	During the 12-week intervention period, protein and energy intake will be estimated based on the average of four 24-hour dietary recall interviews, either by home visits or by phone. Dietary interviews will also be conducted at 12 month follow-up.	Change from: baseline, week 3, week 6, week 9, 3 months and 12 months

Collaborators and Investigators

• Sponsor: University College Absalon
• Collaborators: University of Southern Denmark; Arla Foods; Danish Council for Independent Research; Sundhed og Træning, Slagelse Municipality; Association of Danish Physiotherapists
• Investigators: Principal Investigator: Sanel Teljigovic, PhD student, University College Absalon & University of Southern Denmark

Publications and helpful links

General Publications

• Teljigovic S, Sogaard K, Sandal LF, Dalager T, Nielsen NO, Sjogaard G, Holm L. Individualised physical exercise training and enhanced protein intake in older citizens during municipality-based rehabilitation: protocol for a randomised controlled trial. BMJ Open. 2020 Nov 26;10(11):e041605. doi: 10.1136/bmjopen-2020-041605.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Protein supplementation; Physical exercise training
• Other Study ID Numbers: 8045-00052B (Danish Council for Independent Research); SJ-758 (Other Identifier: Ethics Committee, Region Zealand, Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected during the project period will be sent to "The Danish National Archives" https://www.sa.dk/en/
• IPD Sharing Time Frame: Data will be available immediately after it is submitted to the Danish National Archives.
• IPD Sharing Access Criteria: Data is managed by the Danish National Archives and can be disclosed according to the Danish "notes of archive act / LBK no. 1201 from 28/09/2016".
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No