Physical InactivityNCT05885308
Intervening for Increased Quality of Life Among Older People in Sweden
A study testing Otago in people with Physical Inactivity and Mental Health Issue, run by Karlstad University at 1 site in Sweden.
Trial summary
In the wake of the Covid-19 pandemic, Sweden and other countries have become aware of how life has changed; the world is now a "hybrid world" where many daily activities have moved online. The forced physical isolation has also led to an increase in depression and loneliness, especially among elderly people. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Mental Health Issue
- What is being tested?
- Otago
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2022to 1 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- Understand Swedish
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
In the wake of the Covid-19 pandemic, Sweden and other countries have become aware of how life has changed; the world is now a "hybrid world" where many daily activities have moved online. The forced physical isolation has also led to an increase in depression and loneliness, especially among elderly people. Traditional interventions often involve physical contact, and there are valuable lessons to be learned from this situation, where physical isolation is forced, in order to mitigate the consequences both during and after this pandemic.
The overall purpose of this project is to study physical activity as a way to engage in and maintain an active lifestyle and /or increase the quality of life and limit mental health problems for older people and to study how scalability, accessibility, commitment, and adherence can be improved with flexible programs with digital tools. The specific research question is:
Read more
Is there a difference between the online exercise program and the onsite exercise program in terms of physical activity, balance, motivation, quality of life and mental health?
The results are expected to give insights into how to increase physical activity using flexible programs with digital options and to maintain quality of life among the elderly. By giving the elderly population different options for being physically active and thereby empowering this group, this project contributes to creating a socially sustainable community in which elderly citizens are included.
- Conditions
- Physical Inactivity, Mental Health Issue
- Being tested
- Otago
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtagoBehavioural
Group training is compared with training performed at participants' homes, using an online film
| Study group | Role | What they receive |
|---|---|---|
| Group training | Active comparator | Not described Receives: Behavioral: Otago |
| Online training | Experimental | Not described Receives: Behavioral: Otago |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
The International Physical Activity Questionnaire (IPAQ) (for older people) measures physical activity where the individual self-reports the number of minutes spent inactive and active (Sember et al., 2020).
The number of steps will be measured with a pedometer.
Measured: Time points: 0, 3 and 6 months
Change in leg strength and endurance
30-Second Chair Stand will be used to test leg strength and endurance (Jones et al 2000). The investigator record the number of times the patient stands in 30 seconds. A below average score indicates a risk for falls. For example, a below average score for men aged 70-74 is < 12 and < 10 for women.
Measured: Time points: 0, 3 and 6 months
Secondary outcomes (2)
Change in depression
GDS 20 (Geriatric Depression Scale) is a screening instrument with 20 items to identify depression in older people (Brink, T. L. et al 1982). The questions are answered with yes or no, and answers indicating issues (sometimes yes, sometimes no) are given one point. Scores of 0-5 on the scale are interpreted as depression being unlikely, while scores of 6-20 are interpreted as possible suspicion of depression.
Measured: Time points: 0, 3 and 6 months
Change in Quality Of Life
EQ-5D-5L measures Quality Of Life and comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The maximum score of 1 indicates the best health state In addition, the individual self-report their health on a scale from 0-100, where 100 represented the best health (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/; Burström et al., 2020; Feng, Kohlmann, Janssen, \& Buchholz, 2020).
Measured: Time points: 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion1 Dec 2022
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 Physical InactivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karlstad University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Gustavsson, Karlstad University
- Investigators
- Johanna Gustavsson, PhD, Principal investigator, Karlstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885308
- Sponsor's protocol ID
- 20210102
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nilstomt A, Gustavsson J, Baccman C, Beckman L, Nilson F, Wastlund E. Feasibility of Online and On-Site Physical Activity Delivery Among Older Adults: Mixed Methods Pilot Randomized Controlled Trial. JMIR Form Res. 2026 Oct 13;10:e97824. doi: 10.2196/97824.
PubMed 42869428
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening for Increased Quality of Life Among Older People in Sweden
- ClinicalTrials.gov ID
- NCT05885308
- Acronym / sponsor ID
- 20210102
- Conditions
- Physical Inactivity, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Karlstad UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 1 Jun 2023 (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.
In the wake of the Covid-19 pandemic, Sweden and other countries have become aware of how life has changed; the world is now a "hybrid world" where many daily activities have moved online. The forced physical isolation has also led to an increase in depression and loneliness, especially among elderly people. Traditional interventions often involve physical contact, and there are valuable lessons to be learned from this situation, where physical isolation is forced, in order to mitigate the consequences both during and after this pandemic.
The overall purpose of this project is to study physical activity as a way to engage in and maintain an active lifestyle and /or increase the quality of life and limit mental health problems for older people and to study how scalability, accessibility, commitment, and adherence can be improved with flexible programs with digital tools. The specific research question is:
Is there a difference between the online exercise program and the onsite exercise program in terms of physical activity, balance, motivation, quality of life and mental health?
The results are expected to give insights into how to increase physical activity using flexible programs with digital options and to maintain quality of life among the elderly. By giving the elderly population different options for being physically active and thereby empowering this group, this project contributes to creating a socially sustainable community in which elderly citizens are included.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group training | Active comparator | Behavioral: Otago |
| Online training | Experimental | Behavioral: Otago |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Understand Swedish
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| OtagoGroup training is compared with training performed at participants' homes, using an online film | Behavioural | Group training, Online training |
Primary outcome
Change in physical activity
Time frame: Time points: 0, 3 and 6 months
The International Physical Activity Questionnaire (IPAQ) (for older people) measures physical activity where the individual self-reports the number of minutes spent inactive and active (Sember et al., 2020). The number of steps will be measured with a pedometer.
Change in leg strength and endurance
Time frame: Time points: 0, 3 and 6 months
30-Second Chair Stand will be used to test leg strength and endurance (Jones et al 2000). The investigator record the number of times the patient stands in 30 seconds. A below average score indicates a risk for falls. For example, a below average score for men aged 70-74 is < 12 and < 10 for women.
2 secondary outcomes
Change in depression
Time frame: Time points: 0, 3 and 6 months
Change in Quality Of Life
Time frame: Time points: 0, 3 and 6 months
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 1 Jun 2023.
- Derived from this study: PubMed 42869428Nilstomt A, Gustavsson J, Baccman C, Beckman L, Nilson F, Wastlund E. Feasibility of Online and On-Site Physical Activity Delivery Among Older Adults: Mixed Methods Pilot Randomized Controlled Trial. JMIR Form Res. 2026 Oct 13;10:e97824. doi: 10.2196/97824.
- Individual participant dataSharing planned: No
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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.
Johanna Gustavsson, PhD principal investigator
Karlstad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago in people with Physical Inactivity and Mental Health Issue, run by Karlstad University at 1 site in Sweden.
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 1 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 1 Jun 2023. 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 Sweden. 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 activity (time frame: Time points: 0, 3 and 6 months). The study lists 2 primary outcomes in all. 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 NCT05885308, 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 1 Jun 2023.