NCT05885308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

May 12, 2023

Last Update Submit

May 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in depression

    Time points: 0, 3 and 6 months

  • Change in Quality Of Life

    Time points: 0, 3 and 6 months

Study Arms (2)

Group training

ACTIVE COMPARATOR
Behavioral: Otago

Online training

EXPERIMENTAL
Behavioral: Otago

Interventions

OtagoBEHAVIORAL

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

Group trainingOnline training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Understand Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karlstad University

Karlstad, Värmland County, 65188, Sweden

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Johanna Gustavsson, PhD

    Karlstad University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 12, 2023

First Posted

June 1, 2023

Study Start

April 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 1, 2022

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations