AgingNCT04862481
Physical Function of Older Citizens During Municipality-based Rehabilitation
An observational study of Aging and Rehabilitation, run by University College Absalon at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Rehabilitation, Frailty
- How many people
- 115 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Jan 2021to 12 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- All citizens that are referred to the health/rehabilitation center aged ≥ 65 years 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:
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Older Citizens During Municipality-based Rehabilitation
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:
- To investigate how scores of the SMFA questionnaire are related to measures on different ICF levels
- To describe the characteristics of older citizens starting municipality-based rehabilitation on all ICF levels
- To investigate predictor variables of upper- and lower extremity strength
Read the detailed description
The present study is a sub-study to the Randomized Controlled Trial (NCT04091308).
The present study aims to include 115 participants who will undergo measures specified in the "Outcome" section. The principal investigator of the study will conduct the testing.
- Conditions
- Aging, Rehabilitation, Frailty, Sarcopenia, Fractures, Bone, Musculoskeletal Pain
- Keywords
- SMFA, SF36, ICF, OLDER, REHABILITATION
- Medical subject headings
- Frailty, Sarcopenia, Fractures, Bone, Musculoskeletal Pain, Musculoskeletal Diseases, Muscle Weakness
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA)
Self reported
Measured: Baseline
Secondary outcomes (1)
Measure in health-related quality of life with Short Form 36 (SF-36)
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 two sum scores. Higher scores indicate better health status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start25 Jan 2021
- Primary completion10 Sep 2021
- Study completion12 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Absalon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Sundhed og Træning, Slagelse Municipality, Danish Council for Independent Research
- Responsible party
- Principal investigator, Sanel Teljigovic, University College Absalon
- Investigators
- Sanel Teljigovic, PhD student, Principal investigator, University College Absalon & University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862481
- Sponsor's protocol ID
- SJ758
- Other IDs
- 8045-00052B
- Status last verified
- Mar 2022
- First submitted
- 15 Apr 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38448065
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Older Citizens During Municipality-based Rehabilitation
- ClinicalTrials.gov ID
- NCT04862481
- Acronym / sponsor ID
- SJ758
- Conditions
- Aging, Rehabilitation, Frailty, Sarcopenia, Fractures, Bone, Musculoskeletal Pain
- Keywords
- SMFA, SF36, ICF, OLDER, REHABILITATION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University College AbsalonUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Sundhed og Træning, Slagelse Municipality, Danish Council for Independent Research
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To investigate how scores of the SMFA questionnaire are related to measures on different ICF levels
- To describe the characteristics of older citizens starting municipality-based rehabilitation on all ICF levels
- To investigate predictor variables of upper- and lower extremity strength
Detailed description
The present study is a sub-study to the Randomized Controlled Trial (NCT04091308).
The present study aims to include 115 participants who will undergo measures specified in the "Outcome" section. The principal investigator of the study will conduct the testing.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- All citizens that are referred to the health/rehabilitation center aged ≥ 65 years 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:
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA)
Time frame: Baseline
Self reported
1 secondary outcome
Measure in health-related quality of life with Short Form 36 (SF-36)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 38448065Teljigovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanel Teljigovic, PhD student principal investigator
University College Absalon & University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Rehabilitation, run by University College Absalon at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.