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

University College Absalon

Status: Completed

Conditions: Rehabilitation

Treatments: Other: Usual Care with Protein Supplementation; Other: Usual Care; Other: Individualized Physical Exercise Training with Protein Supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04091308

SJ-758 (Other Identifier)

8045-00052B

Details and patient eligibility

About

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?

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care

Usual Care with Protein Supl.

Experimental group

Description:

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

Treatment:

Other: Usual Care with Protein Supplementation

Individualized Physical Exercise Training with Protein Supl.

Experimental group

Description:

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.

Treatment:

Other: Individualized Physical Exercise Training with Protein Supplementation