Disability PhysicalNCT04531852
Community-based Complex Intervention to Prevent Loss of Physical Function and Disability in Home-dwelling Older Adults
An observational study of Disability Physical, run by University of Southern Denmark at 3 sites in Denmark.
Trial summary
The aim of this study is to compare the effect of 12 weeks group-based exercise program enhanced with 24 weeks health empowerment program (HEP) to an extended usual care condition (the HEP program alone) on physical function, disability, health-related quality of life (HQoL) in home-dwelling older adults at risk for… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disability Physical
- What is being tested?
- CALSTI - Complex Active Lifestyle Intervention and SEMAI - Self-Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 360 participants
- Where
- 3 sitesDenmark
- Study dates
- 22 Jun 2017to 22 Dec 2019
- How long will I take part?
- 24 Weeks
- 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
- Healthy volunteers accepted
- Older adult
Study population: Home-dwelling older adults entitled to a yearly preventive home-visit according to the Danish social act, living in three provincial municipalities in Denmark (Odense, Slagelse and Esbjerg)
Who may be able to join
- Subjects were eligible if at least one of following criteria was met:
- Reduced physical function: SPPB score ≤9
- Fatigability: Pittsburg Fatigability score of 15 or above (≥15)*
- Low physical activity: Physically active ≤1day per week while sitting ≥8 hours on a normal day
- Falls: ≥2 fall over the past year
- Have pain: Brief Pain Inventory interference score ≥20
Who cannot join
- High functioning (Composite SPPB score >10)
- Too physically active (Physically active ≥3 days/week while sitting down <5 hours during a normal day)
- Deadly or critical illness (Cancer, severe heart failure)
- Recent surgery that is expected to affect the intensity of exercise and limit activity#
- Recent fractures that is expected to affect the intensity of exercise and limit activity#
- Chronic pain that prevents regular exercise
Show all 11Show fewer
- Reduced cognitive function (Dementia, Alzheimer's)
- If the subject has completed a rehabilitation process in relation with an operation or fracture, the citizen is free to attend.
- Additional precautions:
- Indication of reduced cognitive function: When Six-Item Cognitive Impairment Screener score <4, subjects are referred to experts for further assessment and determination of cognitive function.
- When unintended weight loss and underweight is detected by the nutritional assessment scheme (score =2), citizens are referred to medical doctor or dietician to recover this, prior to being enrolled in the study.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Municipality of Esbjerg, Health & Care - Project & Development [Esbjerg Kommune - Sundhed & Omsorg - Projekt & Udvikling]
Esbjerg, Southern Denmark, 6700
Municipality of Odense [Odense Kommune]
Odense, Southern Denmark, Odense SV
Municipality of Slagelse [Slagelse Kommune]
Slagelse, Southern Denmark, 4200
About this study
Official title: Tailored Exercise and Behavioural Intervention to Modify Risk Factors Associated With Loss of Physical Function and Disability in Older Adults: Results From the Community-based Welfare Innovation in Primary Prevention Project (WIPP)
The aim of this study is to compare the effect of 12 weeks group-based exercise program enhanced with 24 weeks health empowerment program (HEP) to an extended usual care condition (the HEP program alone) on physical function, disability, health-related quality of life (HQoL) in home-dwelling older adults at risk for disability. Interventions were implemented into existing health care pathways and added to routine preventive programs using a two-armed randomized intervention design with multiple sites.
Read the detailed description
Study design: a two-armed multi-faceted exercise intervention study with two phases: 12 weeks intensive phase followed by 12 weeks maintenance phase.
Intensive phase
- Active condition (exercise + health-empowerment): twice-weekly exercise + 4 health-empowerment sessions
- Comparison condition (health-empowerment) 8 health-empowerment sessions
Maintenance phase
- Active condition (exercise + health-empowerment): 4 health-empowerment sessions
- Comparison condition (health-empowerment): 4 health-empowerment sessions
Sampling method Danish home-dwelling older adults entitled to a nationally regulated preventive home-visit according to the Danish social act, living in three provincial municipalities in the Southern region of Denmark (Odense, Slagelse and Esbjerg) were invited to participate in the WIPP screening as an integrated part of the home-visit. The screening resulted in a risk-profile for functional loss and disability, on which eligibility for interventions was based. The interventions studied here were offered by the municipalities in line with existing services during the project period. In order to enable proper evaluations, citizens who volunteered to participate where randomly allocated to either of the two conditions by sealed randomization procedures. Citizens were informed about this prior to agreeing to participate. Towards the end of the project phase, exceptions from this procedure took place, to accommodate project interests. Tracking of allocation procedure is possible in the dataset. Subject recruitment and allocation, data collection and management as well as interventions were all run by the health care providers (i.e. municipalities).
Registry procedures and other quality factors On-site data collection (self-report and objective assessments) was led by the municipalities. The raw-data was registered in either paper- or digital format depending on the technical prerequisites (access to portable digital equipment and internet connection) of each site.
Paper-format data was subsequently digitalized by municipality staff.
Quality assurance of the validation and registry procedures primarily consisted of three elements:
- Written instructions on how to fill out the individual parts of the data registration were available during the on-site registration, regardless of whether this was done electronically or in paper format. The information was also available during the final registration into the database.
- The written instructions were further qualified by a verbal introduction on how to use the data registry platform and how to fill out the individual parts correctly.
- To assure standardization and validation of data registry, as well the paper-format as the digital databases passed through consecutive cycles of: development (academia and engineer), pilot testing (municipalities), feedback/evaluation (municipalities and academia) and correction (municipalities and academia), until a final product was ready.
The software platform REDCap Cloud (cloud-based data management platform) was used to setup and administer the databases ensuring the required level of data security (GDPR).
The platform allowed the database to be set up with predefined rules of range as well as connections between related data fields. For continuous outcomes on scales that could in principle be infinite (ex. time to complete 10-meter walking distance), predefined rules in the database where based on pilot testing and or qualified by normative data on similar populations when possible. For ordinal and categorical outcomes as well as outcomes restricted to a given range (ex. self-rated health on a VAS scale) the predefined data-base rules were set according to these given restrictions.
The team setting up the database consisted of:
- One primary coder (profession: Engineer)
- Five Testers/Data collector managers from the different data collector sites (municipalities)
- One scientific advisor The outcome data in this database is not routinely collected elsewhere. Therefore, only few items, and only of descriptive character (e.g. sex and age) exist to our knowledge in other databases. Due to GDPR-restrictions these items were not compared to external data sources.
As external validation is not possible for this dataset, an internal verification procedure is developed and will be executed before running the analysis for this study.
- The dataset consists of multiple waves of data-collection. Descriptive items that are considered time constant (e.g. sex, age, group-allocation, subject identification number) will be compared for inconsistencies across waves.
- Initially, descriptive analysis to detect outlying data were performed on all outcome data for each wave separately. Each case will be investigated to identify potential erroneous data.
- Variables with delta-values (i.e. changes from one test-time to another) will be generated for each outcome, and the procedure from point 2 will be followed
- Spot checks will be done across related variables. For example, measured gait speed will be compared to a composite test-score in which gait speed is an important element. If gait speed is very high and the score of the composite test is very low the case will be investigated in order to identify which data is erroneous.
- The database has dedicated a section for comments to the data made by either the test-personnel or the person digitalizing the data. Data will be qualified against these comments before being included in the analysis
- If erroneous data is identified in step 1-5 or in case of doubt about data correctness, data will be marked as missing.
The step-wise verification process will be registered in the database material as Stata .do and Stata .log files, to ensure back-tracking and replicability of the procedure.
The main data dictionary was built in REDCap Cloud on the first language for the different sites (Danish or German).
As the database was later converted into .dta file format, an expansion of the data dictionary was initiated with added information and renaming of certain variables. The main language of the .dta database was then changed to English. All information on both translation, conversion and expansion of the dictionary is stored and available from Stata .do and .log files.
The REDCap Cloud database had a dedicated section for the recruitment pathway with a box to register time of data collection.
All steps in data preparation (changes) and analysis activities are registered both by syntax (.do) and output (.log)
Intervention instructors and the test-personnel were all instructed to identify and register adverse events. The registration was systematically done in all phases of the intervention.
The project had a prespecified number of participants it aimed at recruiting according to the funding requirements.
The database was fitted with options for registering reasons for missing data both for each individual section (i.e. self-report and objective data) and for each wave.
If erroneous data is identified in step 1-5 or in case of doubt, the data will be marked as missing.
Main intervention effects on the primary outcome SPPB and on secondary outcomes of muscle function, physical function, self-reported disability and quality of life as well as hypothesized effect modifiers: self-efficacy, outcome expectancies and barrier management will be estimated using repeated measures mixed models.
To identify significant covariates, adjusted models will be fitted using a step-wise approach.
- Conditions
- Disability Physical
- Being tested
- CALSTI - Complex Active Lifestyle Intervention, SEMAI - Self-Management Intervention
- Keywords
- Low physical function, Functional performance, Disability, Implementation, complex intervention, Primary sector, Exercise, Resistance training, Aged, Int. Classif. of Functioning, Disability and Health (ICF), Primary prevention, Secondary prevention, Self-management, Health behaviour, Health risk behaviour, Motivation, Self-efficacy, Empowerment
- Medical subject headings
- Motor Activity, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALSTI - Complex Active Lifestyle InterventionOther
Also called EXERCISE your shape, [DK: TRÆN din form], [DE: TRAINIERE Deine Form]
A group-based exercise (EX) and health empowerment program (HEP) conducted in the local area.
Structured, progressive resistance (55-60%), balance (10-15%), endurance (10-15%) exercise was delivered twice weekly for 12 weeks under supervision of a trained instructor.
HEP consists of 8 group sessions aiming to facilitate long-term behaviour change, by empowering older citizens to act on current risk behaviours (i.e. low physical activity/exercise, high sedentary behaviour, social isolation, poor dietary habits, incontinence). Four sessions were conducted during the exercise intervention period (phase 1 - intensive), and four sessions in the following 12 weeks (phase 2 - maintenance).
SEMAI - Self-Management InterventionBehavioural
Also called SHAPE your life, [DK: FORM dit liv], [DE: FORME Dein Leben]
A low-cost enhancement of the existing preventive service where citizens are information about relevant health resources. Citizens allocated to SEMAI intervention are offered the health-empowerment program as outlined above, including four extra sessions dedicated to practical experiences with exercising. 24 weeks duration in total, with eight sessions in phase 1 and four sessions in phase 2
| Study group | Role | What they receive |
|---|---|---|
| At risk older adults | Home-dwelling older adults entitled to preventive home visit, who had a risk profile for loss of physical function and disability identified through a multi-domain screening instrument Receives: Other: CALSTI - Complex Active Lifestyle Intervention; Behavioral: SEMAI - Self-Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical function
Physical function was assessed by the Short Physical Performance Battery (SPPB). The SPPB consists of three objective physical function tests: balance, gait and chair-rise.
Sub-scores:
Balance test, range 0-4 points:
- Feet in parallel position (0-9.99 sec = 0 point; ≥10 sec = 1 point) Unable: 0 points: balance test stops
- Feet in semi-tandem position (0-9.99 sec = 0 point; ≥10 sec = +1 point) Unable: balance test stops
- Feet in tandem position (3 to 9.99 sec = +1 point, ≥10 sec = +2 point)
Gait test, range 0-4 points:
Time to walk 3 meters in normal pace
- <3.62 (4 points)
- 3.62 to 4.65 seconds (3 points)
- 4.66 to 6.52 seconds (2 points)
- >6.52 seconds (1 point)
- Unable (0 points)
Chair stand test:
5 repetitions from seated to standing position with arms across chest.
- ≤11.19 seconds (4 points)
- 11.20 to 13.69 seconds (3 points)
- 13.70 to 16.69 seconds (2 points)
- 16.70 seconds (1 point)
- Unable (0 points) The composite SPPB score ranges from
Measured: The SPPB is assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Secondary outcomes (8)
Change in self-reported physical function and disability
Function and disability was measured as two distinct outcomes in The Short Form Late Life Function \& Disability Instrument (SF-LLFDI).
- Function score: 15 questions scored from 5 to 1. Total score ranges between 15 and 75 points with higher score reflecting less difficulty in performing tasks.
- Disability frequency score: Eight items scored from 5 to 1. The potential summed score ranges from 8 to 40 with higher score reflecting less disability.
Measured: Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change in health related quality of life
Assessed by The EuroQol 5-Dimensions 3-level questionnaire (EQ5D-3L)
Measured: Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change in self-efficacy for exercise Exercise
Assessed by the the Self-Efficacy for Exercise Questionnaire. Four response categories scored from 1 to 4 points. Total score range: 9 to 36, with lower scores reflecting higher self-efficacy
Measured: Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change in outcome expectations for Exercise
Assessed by the Multidimensional Outcome Expectations for Exercise Scale (MOOES). Three dimensions: physical (6 items), social (4 items) and self-evaluative expectations (5 items). Five response categories scored from 1 to 5. Higher scores reflects higher outcome expectations
Measured: Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change in perceived barriers for exercise
Assessed by the Sports Related Situational Barriers Scale ranging from 13 to 52 with higher number representing lower level of perceived restriction from exercise because of situational barriers
Measured: Assessed at week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change of management of perceived barriers for exercise
Assessed by the Sports Related Situational Barrier Management Scale ranging from 15 to 30 points with higher number representing more use of management strategies
Measured: Assessed at week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Participation in new community or health activities, after intervention phase 1
Assessed by open ended question for the participation to fill in information about Initiation of participation in activities of any character (health-enhancing, social, community), which the citizen did not do before the intervention.
Measured: Assessed at week 12 (after the intensive phase)
Participation in new community or health activities, after intervention phase 2
Assessed by open ended question for the participation to fill in information about Initiation of participation in activities of any character (health-enhancing, social, community), which the citizen did not do before the intervention.
Measured: Assessed at week 24 (after the maintenance phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start22 Jun 2017
- Primary completion29 Nov 2019
- Study completion22 Dec 2019
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 Disability PhysicalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Esbjerg Municipality, Municipality of Slagelse, Municipality of Odense, Christian Albrechts Universität zu Kiel, Europa Universität Flensburg, AOK Nordwest, Howe Fiedler Stiftung Kiel, Arla Foods
- Responsible party
- Sponsor
- Investigators
- Paolo Caserotti, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531852
- Sponsor's protocol ID
- INTERREG 5a Number: 38-1.0-16
- Status last verified
- Jul 2020
- First submitted
- 5 Aug 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Svensson NH, Thorlund JB, Ollgaard Olsen P, Sondergaard J, Wehberg S, Andersen HS, Caserotti P, Thilsing T. Effect of exercise referral schemes and self-management strategies on healthcare service utilisation among community-dwelling older adults: secondary analyses of two randomised controlled trials. BMJ Open. 2024 Nov 2;14(11):e084938. doi: 10.1136/bmjopen-2024-084938.
PubMed 39488430
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Exercise and Behavioural Intervention to Modify Risk Factors Associated With Loss of Physical Function and Disability in Older Adults: Results From the Community-based Welfare Innovation in Primary Prevention Project (WIPP)
- ClinicalTrials.gov ID
- NCT04531852
- Acronym / sponsor ID
- INTERREG 5a Number: 38-1.0-16
- Conditions
- Disability Physical
- Keywords
- Low physical function, Functional performance, Disability, Implementation, complex intervention, Primary sector, Exercise, Resistance training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Esbjerg Municipality, Municipality of Slagelse, Municipality of Odense, Christian Albrechts Universität zu Kiel, Europa Universität Flensburg, AOK Nordwest, Howe Fiedler Stiftung Kiel, Arla Foods
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 31 Aug 2020 (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.
The aim of this study is to compare the effect of 12 weeks group-based exercise program enhanced with 24 weeks health empowerment program (HEP) to an extended usual care condition (the HEP program alone) on physical function, disability, health-related quality of life (HQoL) in home-dwelling older adults at risk for disability. Interventions were implemented into existing health care pathways and added to routine preventive programs using a two-armed randomized intervention design with multiple sites.
Detailed description
Study design: a two-armed multi-faceted exercise intervention study with two phases: 12 weeks intensive phase followed by 12 weeks maintenance phase.
Intensive phase
- Active condition (exercise + health-empowerment): twice-weekly exercise + 4 health-empowerment sessions
- Comparison condition (health-empowerment) 8 health-empowerment sessions
Maintenance phase
- Active condition (exercise + health-empowerment): 4 health-empowerment sessions
- Comparison condition (health-empowerment): 4 health-empowerment sessions
Sampling method Danish home-dwelling older adults entitled to a nationally regulated preventive home-visit according to the Danish social act, living in three provincial municipalities in the Southern region of Denmark (Odense, Slagelse and Esbjerg) were invited to participate in the WIPP screening as an integrated part of the home-visit. The screening resulted in a risk-profile for functional loss and disability, on which eligibility for interventions was based. The interventions studied here were offered by the municipalities in line with existing services during the project period. In order to enable proper evaluations, citizens who volunteered to participate where randomly allocated to either of the two conditions by sealed randomization procedures. Citizens were informed about this prior to agreeing to participate. Towards the end of the project phase, exceptions from this procedure took place, to accommodate project interests. Tracking of allocation procedure is possible in the dataset. Subject recruitment and allocation, data collection and management as well as interventions were all run by the health care providers (i.e. municipalities).
Registry procedures and other quality factors On-site data collection (self-report and objective assessments) was led by the municipalities. The raw-data was registered in either paper- or digital format depending on the technical prerequisites (access to portable digital equipment and internet connection) of each site.
Paper-format data was subsequently digitalized by municipality staff.
Quality assurance of the validation and registry procedures primarily consisted of three elements:
- Written instructions on how to fill out the individual parts of the data registration were available during the on-site registration, regardless of whether this was done electronically or in paper format. The information was also available during the final registration into the database.
- The written instructions were further qualified by a verbal introduction on how to use the data registry platform and how to fill out the individual parts correctly.
- To assure standardization and validation of data registry, as well the paper-format as the digital databases passed through consecutive cycles of: development (academia and engineer), pilot testing (municipalities), feedback/evaluation (municipalities and academia) and correction (municipalities and academia), until a final product was ready.
The software platform REDCap Cloud (cloud-based data management platform) was used to setup and administer the databases ensuring the required level of data security (GDPR).
The platform allowed the database to be set up with predefined rules of range as well as connections between related data fields. For continuous outcomes on scales that could in principle be infinite (ex. time to complete 10-meter walking distance), predefined rules in the database where based on pilot testing and or qualified by normative data on similar populations when possible. For ordinal and categorical outcomes as well as outcomes restricted to a given range (ex. self-rated health on a VAS scale) the predefined data-base rules were set according to these given restrictions.
The team setting up the database consisted of:
- One primary coder (profession: Engineer)
- Five Testers/Data collector managers from the different data collector sites (municipalities)
- One scientific advisor The outcome data in this database is not routinely collected elsewhere. Therefore, only few items, and only of descriptive character (e.g. sex and age) exist to our knowledge in other databases. Due to GDPR-restrictions these items were not compared to external data sources.
As external validation is not possible for this dataset, an internal verification procedure is developed and will be executed before running the analysis for this study.
- The dataset consists of multiple waves of data-collection. Descriptive items that are considered time constant (e.g. sex, age, group-allocation, subject identification number) will be compared for inconsistencies across waves.
- Initially, descriptive analysis to detect outlying data were performed on all outcome data for each wave separately. Each case will be investigated to identify potential erroneous data.
- Variables with delta-values (i.e. changes from one test-time to another) will be generated for each outcome, and the procedure from point 2 will be followed
- Spot checks will be done across related variables. For example, measured gait speed will be compared to a composite test-score in which gait speed is an important element. If gait speed is very high and the score of the composite test is very low the case will be investigated in order to identify which data is erroneous.
- The database has dedicated a section for comments to the data made by either the test-personnel or the person digitalizing the data. Data will be qualified against these comments before being included in the analysis
- If erroneous data is identified in step 1-5 or in case of doubt about data correctness, data will be marked as missing.
The step-wise verification process will be registered in the database material as Stata .do and Stata .log files, to ensure back-tracking and replicability of the procedure.
The main data dictionary was built in REDCap Cloud on the first language for the different sites (Danish or German).
As the database was later converted into .dta file format, an expansion of the data dictionary was initiated with added information and renaming of certain variables. The main language of the .dta database was then changed to English. All information on both translation, conversion and expansion of the dictionary is stored and available from Stata .do and .log files.
The REDCap Cloud database had a dedicated section for the recruitment pathway with a box to register time of data collection.
All steps in data preparation (changes) and analysis activities are registered both by syntax (.do) and output (.log)
Intervention instructors and the test-personnel were all instructed to identify and register adverse events. The registration was systematically done in all phases of the intervention.
The project had a prespecified number of participants it aimed at recruiting according to the funding requirements.
The database was fitted with options for registering reasons for missing data both for each individual section (i.e. self-report and objective data) and for each wave.
If erroneous data is identified in step 1-5 or in case of doubt, the data will be marked as missing.
Main intervention effects on the primary outcome SPPB and on secondary outcomes of muscle function, physical function, self-reported disability and quality of life as well as hypothesized effect modifiers: self-efficacy, outcome expectancies and barrier management will be estimated using repeated measures mixed models.
To identify significant covariates, adjusted models will be fitted using a step-wise approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At risk older adults | – | Other: CALSTI - Complex Active Lifestyle Intervention, Behavioral: SEMAI - Self-Management InterventionHome-dwelling older adults entitled to preventive home visit, who had a risk profile for loss of physical function and disability identified through a multi-domain screening instrument |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Home-dwelling older adults entitled to a yearly preventive home-visit according to the Danish social act, living in three provincial municipalities in Denmark (Odense, Slagelse and Esbjerg)
Key inclusion criteria (6 listed)
- Reduced physical function: SPPB score ≤9
- Fatigability: Pittsburg Fatigability score of 15 or above (≥15)*
- Low physical activity: Physically active ≤1day per week while sitting ≥8 hours on a normal day
- Falls: ≥2 fall over the past year
- Have pain: Brief Pain Inventory interference score ≥20
Key exclusion criteria (11 listed)
- High functioning (Composite SPPB score >10)
- Too physically active (Physically active ≥3 days/week while sitting down <5 hours during a normal day)
- Deadly or critical illness (Cancer, severe heart failure)
- Recent surgery that is expected to affect the intensity of exercise and limit activity#
- Recent fractures that is expected to affect the intensity of exercise and limit activity#
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALSTI - Complex Active Lifestyle InterventionAlso: EXERCISE your shape, [DK: TRÆN din form], [DE: TRAINIERE Deine Form]A group-based exercise (EX) and health empowerment program (HEP) conducted in the local area. Structured, progressive resistance (55-60%), balance (10-15%), endurance (10-15%) exercise was delivered twice weekly for 12 weeks under supervision of a trained instructor. HEP consists of 8 group sessions aiming to facilitate long-term behaviour change, by empowering older citizens to act on current risk behaviours (i.e. low physical activity/exercise, high sedentary behaviour, social isolation, poor dietary habits, incontinence). Four sessions were conducted during the exercise intervention period (phase 1 - intensive), and four sessions in the following 12 weeks (phase 2 - maintenance). | Other | At risk older adults |
| SEMAI - Self-Management InterventionAlso: SHAPE your life, [DK: FORM dit liv], [DE: FORME Dein Leben]A low-cost enhancement of the existing preventive service where citizens are information about relevant health resources. Citizens allocated to SEMAI intervention are offered the health-empowerment program as outlined above, including four extra sessions dedicated to practical experiences with exercising. 24 weeks duration in total, with eight sessions in phase 1 and four sessions in phase 2 | Behavioural | At risk older adults |
Primary outcome
Change in physical function
Time frame: The SPPB is assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Physical function was assessed by the Short Physical Performance Battery (SPPB). The SPPB consists of three objective physical function tests: balance, gait and chair-rise. Sub-scores: Balance test, range 0-4 points: 1. Feet in parallel position (0-9.99 sec = 0 point; ≥10 sec = 1 point) Unable: 0 points: balance test stops 2. Feet in semi-tandem position (0-9.99 sec = 0 point; ≥10 sec = +1 point) Unable: balance test stops 3. Feet in tandem position (3 to 9.99 sec = +1 point, ≥10 sec = +2 point) Gait test, range 0-4 points: Time to walk 3 meters in normal pace * <3.62 (4 points) * 3.62 to 4.65 seconds (3 points) * 4.66 to 6.52 seconds (2 points) * >6.52 seconds (1 point) * Unable (0 points) Chair stand test: 5 repetitions from seated to standing position with arms across chest. * ≤11.19 seconds (4 points) * 11.20 to 13.69 seconds (3 points) * 13.70 to 16.69 seconds (2 points) * 16.70 seconds (1 point) * Unable (0 points) The composite SPPB score ranges from
8 secondary outcomes
Change in self-reported physical function and disability
Time frame: Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change in health related quality of life
Time frame: Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change in self-efficacy for exercise Exercise
Time frame: Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change in outcome expectations for Exercise
Time frame: Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change in perceived barriers for exercise
Time frame: Assessed at week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Change of management of perceived barriers for exercise
Time frame: Assessed at week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Participation in new community or health activities, after intervention phase 1
Time frame: Assessed at week 12 (after the intensive phase)
Participation in new community or health activities, after intervention phase 2
Time frame: Assessed at week 24 (after the maintenance phase)
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 18 Aug 2021.
- Derived from this study: PubMed 39488430Svensson NH, Thorlund JB, Ollgaard Olsen P, Sondergaard J, Wehberg S, Andersen HS, Caserotti P, Thilsing T. Effect of exercise referral schemes and self-management strategies on healthcare service utilisation among community-dwelling older adults: secondary analyses of two randomised controlled trials. BMJ Open. 2024 Nov 2;14(11):e084938. doi: 10.1136/bmjopen-2024-084938.
- The Welfare Innovation in Primary Prevention project (WIPP) official homepageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Paolo Caserotti, PhD principal investigator
University of Southern Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability Physical, run by University of Southern Denmark at 3 sites 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 6 inclusion and 11 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change in physical function (time frame: The SPPB is assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)). 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 NCT04531852, 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 18 Aug 2021.