Intervening for Increased Quality of Life Among Older People in Sweden

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 Overview

• Status: Completed
• Conditions: Physical Inactivity; Mental Health Issue
• Intervention / Treatment: Behavioral: Otago

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Varmland
    • Karlstad, Varmland, Sweden, 65188
      • Karlstad University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Understand Swedish

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group training	Behavioral: Otago; Group training is compared with training performed at participants' homes, using an online film
Experimental: Online training	Behavioral: Otago; Group training is compared with training performed at participants' homes, using an online film

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Karlstad University
• Investigators: Principal Investigator: Johanna Gustavsson, PhD, Karlstad University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20210102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No