NCT04862481

Brief Summary

When choosing outcomes to assess rehabilitation's effect or progress, it is essential to consider the constructs being measured and their value to the patient and the psychometric properties. Choosing an outcome that reflects all aspects of International Classification levels of Functioning, Disability and Health (ICF) is challenging, especially in heterogeneous groups. However, it is important to know the psychometric properties as this gives important knowledge on how to interpret results and, consequently, how this can inform the patient's care. The Short Musculoskeletal Function Assessment (SMFA) questionnaire can reflect differences in patients' functional status with a broad range of disorders, like for elderly citizens undergoing municipality-based rehabilitation. Nevertheless, since there is no golden standard to measure rehabilitation outcomes, construct validity needs to be established to investigate how scores of SMFA can be related to measures on all levels of ICF. Therefore, this study has three main objectives:

  1. 1.To investigate how scores of the SMFA questionnaire are related to measures on different ICF levels
  2. 2.To describe the characteristics of older citizens starting municipality-based rehabilitation on all ICF levels
  3. 3.To investigate predictor variables of upper- and lower extremity strength

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

April 15, 2021

Last Update Submit

March 21, 2022

Conditions

Keywords

SMFASF36ICFOLDERREHABILITATION

Outcome Measures

Primary Outcomes (1)

  • Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA)

    Self reported

    Baseline

Secondary Outcomes (1)

  • Measure in health-related quality of life with Short Form 36 (SF-36)

    Baseline

Other Outcomes (28)

  • Measure of mobility with The New Mobility Score

    Baseline

  • Measure of the PRISMA-7 score

    Baseline

  • Measure of the Tilburg Frailty Scale score

    Baseline

  • +25 more other outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants from Slagelse municipality's community-based health centre will be recruited in the period January 2021- June 2021 or until 115 men and woman have been included. To detect a correlation coefficient of minimum r=+/-0.3 with a significance level of 0.05 and power of 0.8 between the primary outcome SMFA and the generic health-related quality of life questionnaire SF36 a minimum of 85 participants are needed based on the Fisher's z test. Some studies have shown a response rate for the SMFA to be approximately 65% in cross-sectional studies, we, therefore add another 35% extra participants to the calculated sample size, resulting in a target of 115 participants to be initially included in the study.

You may not qualify if:

  • Inability to speak or read Danish,
  • Active cancer,
  • Upper or lower limb amputations,
  • Hypertension \>180/110,
  • Referred to rehabilitation primarily due to gynecological or neurological conditions (apoplexies) or surgeries where movement restrictions prohibit participating in most of the tests,
  • Discouragement from a general practitioner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sundhed og Træning

Slagelse, Region Sjælland, 4200, Denmark

Location

Related Publications (1)

  • Teljigovic S, Dalager T, Nielsen NO, Holm L, Ejvang MB, Sjogaard G, Sogaard K, Sandal LF. Development and feasibility of a conceptual model for planning individualised physical exercise training (IPET) for older adults: a cross-sectional study. BMJ Open. 2024 Mar 5;14(3):e075726. doi: 10.1136/bmjopen-2023-075726.

MeSH Terms

Conditions

FrailtySarcopeniaFractures, BoneMusculoskeletal PainMusculoskeletal DiseasesMuscle Weakness

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsWounds and InjuriesMuscular DiseasesPain

Study Officials

  • Sanel Teljigovic, PhD student

    University College Absalon & University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 28, 2021

Study Start

January 25, 2021

Primary Completion

September 10, 2021

Study Completion

September 12, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations