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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05885308
Other study ID # 20210102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date December 1, 2022

Study information

Verified date May 2023
Source Karlstad University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 1, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Understand Swedish Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Otago
Group training is compared with training performed at participants' homes, using an online film

Locations

Country Name City State
Sweden Karlstad University Karlstad Varmland

Sponsors (1)

Lead Sponsor Collaborator
Karlstad University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Time points: 0, 3 and 6 months
Primary 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. Time points: 0, 3 and 6 months
Secondary 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. Time points: 0, 3 and 6 months
Secondary 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). Time points: 0, 3 and 6 months
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