NCT07061158

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 2, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

Yoga therapyOlder adultsNon-pharmacological interventionSleep qualityMultidimensional healthRCT

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh Sleep Quality Index (PSQI)

    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.

    Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

Secondary Outcomes (6)

  • Epworth Sleepiness Scale (ESS)

    Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

  • Fatigue Scale-14 (FSS-14)

    Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

  • Montreal Cognitive Assessment-Beijing Version (MoCA-BJ)

    Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

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

    Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

  • Geriatric Depression Scale-15 (GDS-15)

    Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

  • +1 more secondary outcomes

Study Arms (2)

Yoga Intervention Group

EXPERIMENTAL

Participants in this arm received a structured, age-appropriate yoga intervention for a period of 4 months. The program, delivered by certified yoga teachers, integrated physical postures, breathing exercises, and meditation/relaxation techniques designed to improve overall well-being.

Behavioral: Structured Yoga Course Intervention

Usual Lifestyle Group

NO INTERVENTION

Participants in this arm maintained their usual lifestyle during the study period. They did not receive the yoga intervention from this study and only received routine health lifestyle guidance and follow-up. No form of exercise or psychological intervention was conducted during the study.

Interventions

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.

Yoga Intervention Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Sport University,

Beijing, Beijing Municipality, 100084, China

Location

MeSH Terms

Conditions

Sleep Wake DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomnias

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 11, 2025

Study Start

September 2, 2024

Primary Completion

January 15, 2025

Study Completion

April 1, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Locations