Effects of Tele-yoga in Long-term Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Disease

Intervention / Treatment
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* Behavioral: Tele-yoga


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a single-blind parallel two-arm randomized controlled study with 1:1 distribution to intervention and control group. In total 300 persons with long-term conditions will be recruited from three hospitals and randomized to an intervention of medical yoga at home (tele-yoga) using a live videoconference link and a yoga-app on the participants tablet for 12 weeks or a control group receiving individual advice of physical activity. Data will be collected at baseline measurement, after 3 and 6 months.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-yoga<br>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<br>* 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.<br>|
| No Intervention: Individual physical activty advice<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite end-point including physical fuction, health-related quality of life and symptoms of anxiety and depression. | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic capacity/endurance | 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 | 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 | 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 | Actigraph | 3 and 6 months | 
| Cognition | 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 | Minimal insomnia symptom scale is a sleep questionnaire with 3 items that generates ordinal data. Range 0-12. | 3 and 6 months | 
| Exercise Motivation | 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 | Sit to stand test measure the number of uprising from a chair during 30 seconds. | 3 and 6 months | 
| Gait speed | Gait speed test meaures the time it takes in seconds to walk 10 meter at self-selected pace. | 3 and 6 months | 
| Health Health | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yoga, rehabilitation, physical activity, quality of life, anxiety, depression