Intervening for Increased Quality of Life Among Older People in Sweden

Sponsor
Karlstad University (Other)
Overall Status
Completed
CT.gov ID
NCT05885308
Collaborator
(none)
45
1
2
8
5.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Otago
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Intervening for Increased Quality of Life Among Older People in Sweden
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Nov 30, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in physical activity [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.

  2. Change in leg strength and endurance [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.

Secondary Outcome Measures

  1. Change in depression [Time points: 0, 3 and 6 months]

    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.

  2. Change in Quality Of Life [Time points: 0, 3 and 6 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Understand Swedish
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karlstad University Karlstad Varmland Sweden 65188

Sponsors and Collaborators

  • Karlstad University

Investigators

  • Principal Investigator: Johanna Gustavsson, PhD, Karlstad University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johanna Gustavsson, Lecturer, Karlstad University
ClinicalTrials.gov Identifier:
NCT05885308
Other Study ID Numbers:
  • 20210102
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 1, 2023