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NCT Number: NCT07061158

A Multidimensional Health Perspective: Analysis of the Effects of Yoga Intervention on Sleep Disorders in Older Adults

This randomized controlled trial aims to evaluate the impact of a structured yoga intervention on multidimensional health outcomes in older adults with sleep disturbances. A total of 62 participants aged 60 years and older with varying degrees of sleep disorders were recruited and randomly assigned to either a yoga intervention group or a control group. The intervention group received a standardized yoga program for 4 months, conducted twice weekly (60 minutes per session), and guided by certified instructors. The yoga intervention included physical postures, breathing exercises, and meditation/relaxation techniques. Health outcomes were assessed at baseline, mid-intervention (8 weeks), and post-intervention (16 weeks), across five domains: sleep quality, daytime functioning, cognitive performance, physical fitness, and emotional well-being. This study aims to explore the feasibility, safety, and integrative effects of yoga as a non-pharmacological intervention for promoting health in the aging population.

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Key information

Conditions

Sleep Disorders Aging Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Yoga

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Sport University,

Beijing, Beijing Municipality, 100084, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 60 years, conforming to the World Health Organization's definition of the elderly population.
  • Presence of varying degrees of sleep disorder symptoms (e.g., difficulty falling asleep, sleep maintenance difficulties, early morning awakening), but without severe mental illness or other significant underlying diseases affecting sleep (e.g., dementia, severe depression).
  • Possessing basic comprehension abilities, voluntarily participating in the study, and signing informed consent.
  • Capable of cooperating with follow-up and intervention.
  • No severe physical dysfunction, cardiopulmonary disease, or other conditions limiting participation in light physical activities (such as yoga practice).

Exclusion criteria

  • Severe mental disorders, such as schizophrenia, bipolar disorder, or severe depression.
  • Severe cognitive impairment, making it impossible to cooperate with the intervention and subjective questionnaire assessments.
  • Unstable cardiovascular diseases or other major organic diseases (e.g., recent myocardial infarction, end-stage renal failure).
  • Severe visual or auditory impairments that affect the safety and adherence to practice.

Treatment and study plan

Structured Yoga Course Intervention

Behavioral

Participants in this arm received a structured yoga course intervention for a period of 4 months. Sessions were held twice weekly, with each lasting 60 minutes. The curriculum was specifically designed to be gentle, slow-paced, and low-impact, making it suitable for older adults while emphasizing body awareness, mind-body integration, and psychological regulation. The course content included: breathing exercises (e.g., basic abdominal breathing combined with simple movements), asana (posture) practice (e.g., seated chair exercises, standing poses, prone poses, supine poses, and side-lying poses, emphasizing muscle activation, joint flexibility, body balance training, and coordination of breath with movement), and meditation and relaxation (e.g., supine rest, moon breath training, and OM chanting). All classes were instructed by experienced yoga teachers certified by the Yoga Alliance.

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

    The Pittsburgh Sleep Quality Index (PSQI) is an internationally recognized self-rated questionnaire used to assess subjective sleep quality. A higher total score indicates poorer sleep quality. It encompasses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. This study assesses changes in the PSQI total score to determine the impact of yoga intervention on the overall sleep status of older adults with sleep disorders.

Secondary outcomes

  1. Epworth Sleepiness Scale (ESS)

    Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

    The Epworth Sleepiness Scale (ESS) primarily assesses the likelihood of a participant experiencing sleepiness in various daily situations, serving as a common tool to measure daytime alertness. Higher scores indicate greater levels of sleepiness.

  2. Fatigue Scale-14 (FSS-14)

    Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

    The Fatigue Scale-14 (FSS-14) assesses the subjective feeling of fatigue in daily life, reflecting the degree of exhaustion caused by sleep disorders. Higher scores indicate greater fatigue.

  3. Montreal Cognitive Assessment-Beijing Version (MoCA-BJ)

    Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

    The Montreal Cognitive Assessment-Beijing Version (MoCA-BJ) is a widely used cognitive screening tool for older adults, covering multiple cognitive domains such as memory, attention, language, visuospatial ability, calculation, and orientation

  4. Lower Limb Major Muscle Group Strength (Quadriceps Femoris, Hamstrings, Triceps Surae, Tibialis Anterior, Iliopsoas)

    Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

    Assesses the strength of major lower limb muscle groups, including the quadriceps femoris, hamstrings, triceps surae, tibialis anterior, and iliopsoas. Maximum isometric contraction values for both sides are recorded using a MICROFET2 standardized electronic dynamometer to comprehensively reflect individual lower limb support and gait stability.

  5. Geriatric Depression Scale-15 (GDS-15)

    Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

    The Geriatric Depression Scale-15 (GDS-15) is suitable for rapid screening of depressive symptoms in older adults. Higher scores indicate a greater tendency towards depression.

  6. Self-Rating Anxiety Scale (SAS)

    Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

    The Self-Rating Anxiety Scale (SAS) is used to assess subjective anxiety levels. Higher scores indicate greater anxiety.

Sponsors and collaborators

Lead sponsor

Beijing Sport University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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