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Individualized Physical Exercise Training and Enhanced Protein Intake During Rehabilitation of Elderly Citizens

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ClinicalTrials.gov Identifier: NCT04091308
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
University of Southern Denmark
Sundhed og Træning, Slagelse Municipality
Arla Foods
Danish Council for Independent Research
Association of Danish Physiotherapists
Information provided by (Responsible Party):
Sanel Teljigovic, University College Absalon

Tracking Information
First Submitted Date  ICMJE September 4, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date October 15, 2019
Estimated Study Start Date  ICMJE October 21, 2019
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
Short Musculoskeletal Function Assessment (SMFA) - Dysfunction Index [ Time Frame: Change from: baseline to 3 months (primary endpoint) and 12 months ]
Self reported
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04091308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
  • Mean change from baseline in mobility with The New Mobility Score [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in the PRISMA-7 score [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in the Tilburg Frailty Scale score [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in health-related quality of life on SF-36 [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Measure of pain, physical activity level and educational level [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in weight [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Weight (in kilograms). Weight and height will be combined to report BMI in kg/m^2.
  • Measure of height at baseline [ Time Frame: Baseline ]
    Height (in meters). Weight and height will be combined to report BMI in kg/m^2.
  • Mean change from baseline in blood pressure [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Systolic and diastolic blood pressure (mmHg) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.
  • Mean change from baseline in resting heart rate [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Resting heart rate (in beats per minute) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.
  • Mean change from baseline in body composition measured with a bioimpedance device [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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
  • Mean change from baseline in the basic metabolic rate (BMR) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    BMR will be estimated by a bioelectrical impedance analysis device "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyze".
  • Mean change from baseline of Waist-To-Hip ratio [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in maximal isometric voluntary contraction of leg extension [ Time Frame: Change from: baseline to 3 months and 12 months ]
    A maximal isometric voluntary contraction (in newtons) for knee extension will be performed using a strain gauge.
  • Mean change from baseline in handgrip strength [ Time Frame: Change from: baseline to 3 months and 12 months ]
    The handgrip strength (in kilograms) will be measured using a hydraulic handgrip dynamometer (SAEHAN).
  • Mean change from baseline in leg press strength [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Five repetitions maximum (RM) strength tests will be performed in the leg press (in kilograms) to calculate 1 RM.
  • Mean change from baseline in knee extension strength [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Five repetitions maximum (RM) strength tests will be performed in knee extension (in kilograms) to calculate 1 RM.
  • Mean change from baseline in calf extension strength [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Five repetitions maximum (RM) strength tests will be performed in the calf extension (in kilograms) to calculate 1 RM.
  • Mean change from baseline in function measured with the 2 minutes walk test (2MWT) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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).
  • Mean change from baseline in heart rate during 2 minutes walk test (2MWT) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Heart rate (in BPM) will be measured (using the Apple Watch serie 5) before and right after the 2MWT.
  • Mean change from baseline in heart rate before and after the 2 minutes walk test (2MWT) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Heart rate (in BPM) will be measured (using the Apple Watch serie 5) before and right after the 2MWT.
  • Mean change from baseline in The Borg Rating of Perceived Exertion before and after the 2 minutes walk test (2MWT) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    The Borg Rating of Perceived Exertion will be used to estimate the activity intensity before and right after the 2MWT.
  • Mean change from baseline in function measured with the Timed Up and Go test (TUG) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in balance measured with the Tandem test [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Balance and reaction time for upper and lower extremity [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Measures for balance and reaction time will be collected using the "Fysiometer," and the protocols within the "Fysiometer" software will be followed.
  • Protein and energy intake [ Time Frame: Change from: baseline, week 3, week 6, week 9, 3 months and 12 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Mean change from baseline in mobility with The New Mobility Score [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in the PRISMA-7 score [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in the Tilburg Frailty Scale score [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in health-related quality of life on SF-36 [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Measure of pain, physical activity level and educational level [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in weight [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Weight (in kilograms). Weight and height will be combined to report BMI in kg/m^2.
  • Measure of height at baseline [ Time Frame: Baseline ]
    Height (in meters). Weight and height will be combined to report BMI in kg/m^2.
  • Mean change from baseline in blood pressure [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Systolic and diastolic blood pressure (mmHg) will be measured using the Omron M3 blood pressure and resting heart rate monitor.
  • Mean change from baseline in resting heart rate [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Resting heart rate (in beats per minute) will be measured using the Omron M3 blood pressure and resting heart rate monitor.
  • Mean change from baseline in body composition measured with a bioimpedance device [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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), skeletal 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
  • Mean change from baseline in the basic metabolic rate (BMR) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    BMR will be estimated by a bioelectrical impedance analysis device "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyze".
  • Mean change from baseline of Waist-To-Hip ratio [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in maximal isometric voluntary contraction of leg extension [ Time Frame: Change from: baseline to 3 months and 12 months ]
    A maximal isometric voluntary contraction (in newtons) for knee extension will be performed using a strain gauge.
  • Mean change from baseline in handgrip strength [ Time Frame: Change from: baseline to 3 months and 12 months ]
    The handgrip strength (in kilograms) will be measured using a digital handgrip dynamometer.
  • Mean change from baseline in leg press strength [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Five repetitions maximum (RM) strength tests will be performed in the leg press (in kilograms) to calculate 1 RM.
  • Mean change from baseline in knee extension strength [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Five repetitions maximum (RM) strength tests will be performed in knee extension (in kilograms) to calculate 1 RM.
  • Mean change from baseline in calf extension strength [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Five repetitions maximum (RM) strength tests will be performed in the calf extension (in kilograms) to calculate 1 RM.
  • Mean change from baseline in function measured with the 2 minutes walk test (2MWT) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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).
  • Mean change from baseline in function measured with the Timed Up and Go test (TUG) [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Mean change from baseline in balance measured with the Tandem test [ Time Frame: Change from: baseline to 3 months and 12 months ]
    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.
  • Balance and reaction time for upper and lower extremity [ Time Frame: Change from: baseline to 3 months and 12 months ]
    Measures for balance and reaction time will be collected using the "Fysiometer," and the protocols within the "Fysiometer" software will be followed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Physical Exercise Training and Enhanced Protein Intake During Rehabilitation of Elderly Citizens
Official Title  ICMJE Individualized Physical Exercise Training and Enhanced Protein Intake During Rehabilitation of Elderly Citizens
Brief Summary 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?
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rehabilitation
Intervention  ICMJE
  • Other: Usual Care
    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 Name: ARLA PROTINO
  • 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 Name: ARLA PROTINO
Study Arms  ICMJE
  • Active Comparator: Usual Care
    Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.
    Intervention: Other: Usual Care
  • Experimental: Usual Care with Protein Supl.
    Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.
    Intervention: Other: Usual Care with Protein Supplementation
  • 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.
    Intervention: Other: Individualized Physical Exercise Training with Protein Supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
177
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 >180/90,
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sanel Teljigovic, PhD student +4572482689 steljigovic@health.sdu.dk
Contact: Karen Søgaard, Professor 004565504409 ksogaard@health.sdu.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04091308
Other Study ID Numbers  ICMJE 8045-00052B
SJ-758 ( Other Identifier: Ethics Committee, Region Zealand, Denmark )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data collected during the project period will be sent to "The Danish National Archives" https://www.sa.dk/en/
Supporting Materials: Study Protocol
Time Frame: Data will be available immediately after it is submitted to the Danish National Archives.
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".
URL: https://www.sa.dk/en/
Responsible Party Sanel Teljigovic, University College Absalon
Study Sponsor  ICMJE University College Absalon
Collaborators  ICMJE
  • University of Southern Denmark
  • Sundhed og Træning, Slagelse Municipality
  • Arla Foods
  • Danish Council for Independent Research
  • Association of Danish Physiotherapists
Investigators  ICMJE
Principal Investigator: Sanel Teljigovic, PhD student University College Absalon & University of Southern Denmark
PRS Account University College Absalon
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP