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

NCT ID: NCT04091308

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2023-06-01

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.

Conditions

Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.

Usual Care with Protein Supl.

Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.

Group Type: EXPERIMENTAL

Usual Care with Protein Supplementation

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Individualized Physical Exercise Training with Protein Supplementation

Intervention Type: OTHER

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.

Interventions

Usual Care

Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

ARLA PROTINO; ARLA PROTINO

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Sundhed og Træning, Slagelse Municipality

UNKNOWN

Sponsor Role: collaborator

Arla Foods

INDUSTRY

Sponsor Role: collaborator

Danish Council for Independent Research

OTHER

Sponsor Role: collaborator

Association of Danish Physiotherapists

OTHER

Sponsor Role: collaborator

University College Absalon

OTHER

Sponsor Role: lead

Responsible Party

Sanel Teljigovic

Senior lecturer, PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanel Teljigovic, PhD student

Role: PRINCIPAL_INVESTIGATOR

University College Absalon & University of Southern Denmark

Locations

Sundhed og Træning

Slagelse, Region Sjælland, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 33243811 (View on PubMed)

Other Identifiers

SJ-758

Identifier Type: OTHER

Identifier Source: secondary_id

8045-00052B

Identifier Type: -

Identifier Source: org_study_id