Effects of Tele-yoga in Long-term Conditions

Overview

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.

Full Title of Study: “Effects of Tele-yoga on Physical Function, Health-related Quality of Life, Symptoms of Anxiety and Depression in Long-term Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 31, 2023

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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
  • 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.
  • 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’.
  • Physical activity
    • Time Frame: 3 and 6 months
    • Actigraph
  • 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.
  • 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.
  • 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.
  • Lower body strength
    • Time Frame: 3 and 6 months
    • Sit to stand test measure the number of uprising from a chair during 30 seconds.
  • 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.
  • 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).
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Linkoeping University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anna Stroemberg, professor – Linkoeping University
  • Overall Official(s)
    • Anna Stromberg, PhD, Principal Investigator, Linkoping University

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