Clinical trial NCT03703609: Effects of Tele-yoga in Long-term Conditions
Official title: Effects of Tele-yoga on Physical Function, Health-related Quality of Life, Symptoms of Anxiety and Depression in Long-term Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: yoga
rehabilitation
physical activity
quality of life
anxiety
depression
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2018-10-12
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite end-point including physical fuction, health-related quality of life and symptoms of anxiety and depression.
timeFrame: 3 months
Secondary outcomes:
measure: Aerobic capacity/endurance
timeFrame: 3 and 6 months
measure: Symptoms of Anxiety and Depression
timeFrame: 3 and 6 months
measure: Health-related quality of life
timeFrame: 3 and 6 months
measure: Physical activity
timeFrame: 3 and 6 months
measure: Cognition
timeFrame: 3 and 6 months
measure: Sleep
timeFrame: 3 and 6 months
measure: Exercise Motivation
timeFrame: 3 and 6 months
measure: Lower body strength
timeFrame: 3 and 6 months
measure: Gait speed
timeFrame: 3 and 6 months
measure: Health Health
timeFrame: 3 and 6 months
measure: Life satisfaction
timeFrame: 3 and 6 months
Other outcomes:
measure: HcCRP
timeFrame: 3 and 6 months
measure: Cost-effectiveness
timeFrame: 6 months
measure: Adherence
timeFrame: 3 months
measure: Qualitative interviews
timeFrame: 3 months
measure: Quality-adjusted life-year (QALY)
timeFrame: 6 months
Locations:
city: Eskilstuna
country: Sweden
facility: Mälardals hospital
city: Jönköping
country: Sweden
facility: Ryhov hospital
city: Linköping
country: Sweden
facility: Linköpings University hospital
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
Study officials:
affiliation: Linkoeping University
name: Anna Stromberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: