Effects of Tele-yoga in Long-term Conditions (TELEYOGA)

November 20, 2023 updated by: Anna Stroemberg, Linkoeping University

Effects of Tele-yoga on Physical Function, Health-related Quality of Life, Symptoms of Anxiety and Depression in Long-term Conditions

Long-term illness is common in the Swedish population, especially among older people. These conditions are often associated with impaired quality of life due to high physical and psychological symptom-burden. Medical Yoga is a therapeutic form of Kundalini Yoga with simple movements, breathing exercises and meditation. For people with serious long-term illness, it can be difficult to attend regular yoga-classes. In this study, the investigators therefore set out to develop a tele-yoga intervention and evaluate the impact of medical yoga remotely at home with regard to physical function, quality of life, symptoms of anxiety and depression, biomarkers, sleep and cognition in people with long-term conditions. Health care utilisation as well as satisfaction and experiences with the exercise form and technology used will also be assessed. The evaluation will be conducted in 150 people with long-term illness recruited from three hospitals (one university hospital and two county hospital) randomised to receive either an intervention with medical yoga remotely at home (tele-yoga) for 12 weeks or a control group receiving individualised training to the same extent. The tele-yoga intervention will be provided remotely in the home via a video-transferred yoga instructor twice a week using a tablet and an app for individual daily exercise. Data will be collected at baseline, after 3 and 6 months.

Despite evidence that physical activity improves quality of life and functional capacity and probably survival, it is difficult to motivate and enable elderly people with long-term conditions to engage in physical and mental rehabilitation. In this study, we will test whether a new method conveyed through a technical solution remotely can increase patients' activity and well-being through allowing tele-yoga at home. Can health care resources be reduced, financial gains can also be made.

The study aims to evaluate the impact of medical yoga remotely at home with regard to physical function, quality of life, symptoms of anxiety and depression, biomarkers, sleep and cognition in people with long-term conditions. The investigators will also measure health care utilisation as well as satisfaction and experiences with the exercise form and technology used. The evaluation will be conducted in 300 people with long-term illness randomised to either tele-yoga or a control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A sub-study will be conducted exploring physiological effects of yoga in participants with heart failure. The sub-study will include 40 of the patients with heart failure included in the main study. In the sub-study six additional measures will be performed at baseline and after 3 months in 20 study participants with heart failure in the intervention group; ergospirometry, echocardiography, Holter ECG, microcirculation using the epos system, maximal inspiratory and expiratory pressure. There will be four additional measures in 20 participants from the control-group at baseline and after 3 months; Holter ECG, microcirculation using the epos system and maximal inspiratory and expiratory pressure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
311

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Eskilstuna, Sweden
        • Mälardals hospital
      • Jönköping, Sweden
        • Ryhov Hospital
      • Linköping, Sweden
        • Linköpings University Hospital
      • Norrköping, Sweden
        • Vrinnevi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Long-term illness and cared for at the cardiology clinic or intensive care clinic for at least 48 hours in the last 3-36 months.
  • Clinically stable condition at the inclusion.

Exclusion Criteria:

  • Inability to fill in questionnaires.
  • Inability to participate in the intervention.
  • Expected survival of less than 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tele-yoga
Intervention of doing medical yoga at home (tele-yoga) using (1) an online videoconference system (zoom) for particpating in group-yogaled by a live yoga instructor for 60 minutes twice a week and (2) daily individual yoga for a minimum of 10 minutes using a yoga-app. Participants are provided with a tablet with conference system zoom and yoga app for 12 weeks
Behavioral: Tele-yoga
Participants will get a 60 min tele-yoga session biweekly led by a certified medical yoga instructor via live videoconference link on the participants tablet. Each participant will perform a total of 20-24 yoga instructor-led sessions over a 12-week period. A session will contain 10 min breathing exercises, 40 min of yoga and 10 min relaxation/meditation. Before and at the end of each session, participants can discuss their experiences or ask questions to the instructor online. The tablet also includes an app with instructions (text, pictures, and sound files) for yoga positions, breathing and meditation. Participants are encouraged to practice yoga at home individually with one goal of one session a day for a minimum of 10 minutes.
No Intervention: Individual physical activty advice
The active control group will receive advice to be physically active that corresponds to the intervention group in time and effort, equivalent to 60 minutes for 2 days a week and a minimum of 10 minutes for 5 days a week. To compensate for the extra attention received by the intervention group by the instructor via tele-yoga group, the participants in the activecontrol group's patients will be dialed or have SMS contact (the participant chooses a type of contact) with a physiotherapist or nurse after 2, 4, 8 and 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite end-point including physical fuction, health-related quality of life and symptoms of anxiety and depression.
Time Frame: 3 months
The composite weighed score consists of physical ability (6 min walking test), Health-realted quality of Life (EQ-5D) and symptom of anxiety and depression (HADS). Based on the change in these 3 variables, a patient can get a score between -3 and + 3 based on the increase, decrease or no change in 6 min walk test, HADS, and EQ5D. The weighted variable will be categorised as improved, deteriorated or unchanged after 3 months.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aerobic capacity/endurance
Time Frame: 3 and 6 months
6 min walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. Measures the distance in meters covered over a time of 6 minutes
3 and 6 months
Symptoms of Anxiety and Depression
Time Frame: 3 and 6 months
Hospital anxiety and depression scale is a 14 item scale that generates ordinal data 0-3. Seven of the items relate to anxiety, range 0-21 and seven relate to depression, range 0-21.
3 and 6 months
Health-related quality of life
Time Frame: 3 and 6 months
The EQ-5D 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 responses generate ordinal data from 1-5 for each dimension. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale 0-100 mm, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
3 and 6 months
Physical activity
Time Frame: 3 and 6 months
Actigraph
3 and 6 months
Cognition
Time Frame: 3 and 6 months
Montreal Cognitive Assessment including short-term memory, visual abilities, executive functions, attention, concentration, working memory, language and orientation to time and place. Scores range between 0 and 30. A score of 26 or over is considered to be normal.
3 and 6 months
Sleep
Time Frame: 3 and 6 months
Minimal insomnia symptom scale is a sleep questionnaire with 3 items that generates ordinal data. Range 0-12.
3 and 6 months
Exercise Motivation
Time Frame: 3 and 6 months
The Exercise Motivation Index includes 15 items that generates ordinal data on the motives of participating in physical exercise. Range 0-60.
3 and 6 months
Lower body strength
Time Frame: 3 and 6 months
Sit to stand test measure the number of uprising from a chair during 30 seconds.
3 and 6 months
Gait speed
Time Frame: 3 and 6 months
Gait speed test meaures the time it takes in seconds to walk 10 meter at self-selected pace.
3 and 6 months
Health Health
Time Frame: 3 and 6 months
One general health question from RAND 36 genreating an ordinal data response from 1 (poor health)-5 (excellent health).
3 and 6 months
Life satisfaction
Time Frame: 3 and 6 months
Cantril ladder of Life is a measurement technique that asks people to rate their present, past, and anticipated future satisfaction with life on a scale anchored by their own identified values from 1 to 10.
3 and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HcCRP
Time Frame: 3 and 6 months
High sensitivity C-reactive protein (CRP) will be used as a routine marker of inflammation. Blood samples were collected while the patients were at rest in a supine position using EDTA-vials. The vials were chilled on ice before centrifugation at 3000 g, 4oC and then frozen at -70ºC. No sample was thawed more than twice. CRP was analysed using latex-enhanced turbidimetric immunoassay (Roche Diagnostics GmbH, Vienna, Austria) with a lower detection limit of 0.03 mg/L and coefficient of variation of 1.7%.
3 and 6 months
Cost-effectiveness
Time Frame: 6 months
Health care utilisation through medical charts/registries. The cost of the intervention will also be calculated.
6 months
Adherence
Time Frame: 3 months
The adherence will be measured through attendance in video groups and the use of yoga app The minutes each participant have used to perform individual yoga training will be measured via a statistical software incorporated in the yoga app.
3 months
Qualitative interviews
Time Frame: 3 months
Telephone interviews about yoga, tele-yoga, user-friendliness and use of technology in the tele-yoga group
3 months
Quality-adjusted life-year (QALY)
Time Frame: 6 months
Will be obtained from the EQ-5D
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna Stromberg, PhD, Linköping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/225-31

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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