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

NCT04091308 | Completed

• 2 other identifiers: 8045-00052BSJ-758
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Rehabilitation

Keywords

Exercise; Protein supplementation; Physical exercise training

Outcome Measures

Primary Outcomes (1)

• Short Musculoskeletal Function Assessment (SMFA) - Dysfunction Index

  Self reported

  Change from: baseline to 3 months (primary endpoint) and 12 months

Secondary Outcomes (25)

• Mean change from baseline in mobility with The New Mobility Score

  Change from: baseline to 3 months and 12 months

• Mean change from baseline in the PRISMA-7 score

  Change from: baseline to 3 months and 12 months

• Mean change from baseline in the Tilburg Frailty Scale score

  Change from: baseline to 3 months and 12 months

• Mean change from baseline in health-related quality of life on SF-36

  Change from: baseline to 3 months and 12 months

• Measure of pain, physical activity level and educational level

  Change from: baseline to 3 months and 12 months

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Usual Care with Protein Supl.

EXPERIMENTAL

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

Other: Usual Care with Protein Supplementation

Individualized Physical Exercise Training with Protein Supl.

EXPERIMENTAL

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

Interventions

Usual Care OTHER

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

Usual Care

Usual Care with Protein Supplementation 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.

Also known as: ARLA PROTINO

Usual Care with Protein Supl.

Individualized Physical Exercise Training with Protein Supplementation 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.

Also known as: ARLA PROTINO

Individualized Physical Exercise Training with Protein Supl.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Absalon: lead
• University of Southern Denmark: collaborator
• Sundhed og Træning, Slagelse Municipality: collaborator
• Arla Foods: collaborator
• Danish Council for Independent Research: collaborator
• Association of Danish Physiotherapists: collaborator

Study Sites (1)

Sundhed og Træning

Slagelse, Region Sjælland, 4200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33243811 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sanel Teljigovic, PhD student

  University College Absalon & University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer, PhD-student

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 16, 2019
• Study Start: January 10, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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".

Locations

DK (1)