Task-Specific Training vs. Yoga (With and Without Perturbation) for Balance and Leg Strength in Older Adults

NCT06875388 | Active Not Recruiting DMC

• 1 other identifier: IRB#545-24
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental study is designed to observe the effectiveness of task-specific training vs yoga with and without perturbation on reactive balance and leg strength in older individuals in Islamabad/Rawalpindi, Pakistan. Older adults meeting the criteria will be grouped into 4 intervention groups. One group will be doing task-specific training, the second will be doing yoga poses, the third will be doing task-specific with perturbation, and 4th will be doing yoga poses with perturbation. Baseline readings through manual release from lean, minbest test, manual muscle testing (MMT), WHO quality of life, Barthel index, 30-sec sit-to-stand test, Stroop test, and mini-mental state examination, will be taken before starting the intervention, and post-intervention readings will be taken after 3 months of intervention. After this, all readings will be retaken 1 month after stopping the intervention

Conditions

Cognitive Functioning of Healthy Individuals; Balance; Strength, Muscle; Quality of Life (QOL)

Keywords

Task-specific training; yoga poses; perturbation; reactive balance; overall leg strength

Outcome Measures

Primary Outcomes (5)

• Manual Release from Lean (MRFL) Test:

  This methodology assesses balance recovery using MFRL and CRFL-inspired tests. Participants wear a safety harness and stand on a standardized foot placement template (17cm heel distance, 14° angle). Trained personnel and a cushioned mat ensure safety. The test involves a controlled forward lean (≤15°) with sudden release by an administrator. A practice trial familiarizes participants before three test trials. Balance recovery is assessed qualitatively (e.g., stepping, arm use) and quantitatively (distance covered, time). Core muscles, including glutes, hamstrings, and abdominals, stabilize movement. Safety measures include verbal cues, secure harness checks, and moderate perturbations.

  Outcome measure will be assessed at baseline as a pre-intervention procedure. 2nd time point will be 'immediately after the six-week intervention.' Third time point will be 'through study completion, an average of 3 months

• Mini Balance Evaluation Systems Test (Mini-BESTest)

  The Mini-BESTest is a clinical tool assessing dynamic balance and postural control in individuals with neurological conditions, older adults, and those recovering from injuries. It consists of 14 items across four categories: Anticipatory Postural Adjustments, Reactive Postural Control, Sensory Orientation, and Dynamic Gait. Each item is scored from 0-2, with a maximum score of 28; ≤19 indicates a high fall risk. The test is more sensitive than traditional balance assessments and helps guide rehabilitation by identifying specific impairments and tracking progress. It is widely used in neurology, geriatrics, and rehabilitation for fall prevention and treatment planning.

  Outcome measure will be assessed at baseline as a pre-intervention procedure. 2nd time point will be 'immediately after the six-week intervention.' Third time point will be 'through study completion, an average of 3 months

• Manual Muscle Testing (MMT):

  Manual Muscle Testing (MMT) is a clinical assessment used to evaluate muscle strength and function by applying resistance against a patient's voluntary movement. It helps diagnose neuromuscular conditions, monitor progress, and guide rehabilitation. MMT grades muscle strength on a 0-5 scale: 0 (no contraction), 1 (visible contraction, no movement), 2 (movement without gravity), 3 (movement against gravity), 4 (movement against moderate resistance), and 5 (normal strength). Testing involves positioning the patient, stabilizing the joint, and applying resistance while observing for compensatory movements. MMT is widely used in physical therapy, neurology, and sports medicine to assess muscular imbalances, nerve injuries, and overall functional capacity. Though subjective, when combined with functional tests and dynamometry, it provides valuable insight into muscle performance, aiding in treatment planning and progress tracking for various musculoskeletal and neurological conditions.

  Outcome measure will be assessed at baseline as a pre-intervention procedure. 2nd time point will be 'immediately after the six-week intervention.' Third time point will be 'through study completion, an average of 3 months

• 30- secs sit to stand test

  The 30-Second Sit-to-Stand Test (30s STS) assesses lower body strength, endurance, and balance, especially in older adults and those with mobility impairments. Participants repeatedly stand from a sturdy chair for 30 seconds, with total repetitions recorded. It evaluates leg strength and functional power, essential for daily activities and fall prevention. Scores ≤12 indicate increased fall risk. Key muscles involved include the quadriceps, gluteus maximus, hamstrings, calves, and core. The test is widely used in clinical and research settings to track rehabilitation progress and guide fall prevention strategies. Its simplicity makes it a reliable tool for identifying mobility decline and designing targeted interventions.

  Outcome measure will be assessed at baseline as a pre-intervention procedure. 2nd time point will be 'immediately after the six-week intervention.' Third time point will be 'through study completion, an average of 3 months

• Mini Mental State Examination (MMSE)

  used For mental status and cognitive function The Mini-Mental State Examination (MMSE) scores range from 0 to 30, with higher scores indicating better cognitive function; a score of 24 or higher is generally considered normal, while scores below 24 may suggest cognitive impairment. Here's a more detailed breakdown of the scoring guide and what the scores mean: Scoring: Maximum Score: 30 Normal: 24 or higher Mild Cognitive Impairment: 18-23 Moderate Cognitive Impairment: 10-17 Severe Cognitive Impairment: 0-9 \<23 is generally accepted as indicating cognitive impairment Areas Assessed: The MMSE assesses five key areas of cognitive function: Orientation: (Time and Place) Registration: (Repeating named prompts) Attention and Calculation: (Serial sevens or spelling "world" backward) Recall: (Registration recall) Language: (Naming a pencil and a watch)

  Outcome measure will be assessed at baseline as a pre-intervention procedure. 2nd time point will be 'immediately after the six-week intervention.' Third time point will be 'through study completion, an average of 3 months

Secondary Outcomes (3)

• World Health Organization Quality of Life Brief Version ( WHOQOL-BREF )

  Outcome measure will be assessed at baseline as a pre-intervention procedure. 2nd time point will be 'immediately after the six-week intervention.' Third time point will be 'through study completion, an average of 3 months

• The Barthel Scale/Index (BI)

  Outcome measure will be assessed at baseline as a pre-intervention procedure. 2nd time point will be 'immediately after the six-week intervention.' Third time point will be 'through study completion, at an average of 3 months

• Mini Stroop test

  Outcome measure will be assessed at baseline as a pre-intervention procedure. 2nd time point will be 'immediately after the six-week intervention.' Third time point will be 'through study completion, at an average of 3 months

Study Arms (4)

Group A: task specific training

EXPERIMENTAL

Group A will receive a basic protocol of 40 minutes involving 10 minutes of warm up 10 10 mins of task-specific training and 10 mins of leg strength exercises and 10 mins of cool-down exercises.

Other: Task specific Training

Group B specific Yoga poses

EXPERIMENTAL

For group B, a series of yoga poses will be applied. Each training session consists of a 10-minute warm-up, 20 minutes of yoga exercises, and a 10-minute cool-down.

Other: Specific Yoga Poses

Group C Task specific with perturbation

EXPERIMENTAL

Group C will be 40 minutes involving 10 minutes warm up 10 mins of task-specific training involving perturbation and 10 mins of leg strength exercises involving perturbation and 10 mins of cool-down exercises.

Other: Tasl specific Training with perturbation

Group D Specific yoga Poses with Perturbation

EXPERIMENTAL

Group D training session consists of a 10-minute warm-up, 20 minutes of yoga exercises with perturbation, and a 10-minute cool-down

Other: Specific yoga poses with perturbation

Interventions

Task specific Training OTHER

Group A will receive a basic protocol of 40 minutes involving 10 minutes of warm up 10 10 mins of task-specific training 10 mins of leg strength exercises and 10 mins of cool-down exercises.

Group A: task specific training

Specific Yoga Poses OTHER

For group B, a series of yoga poses will be applied. Each training session consists of a 10-minute warm-up, 20 minutes of yoga exercises, and a 10-minute cool-down.

Group B specific Yoga poses

Tasl specific Training with perturbation OTHER

GGroup C will be 40 minutes involving 10 minutes of warm-up 10 minutes of task-specific training involving perturbation 10 mins of leg strength exercises involving perturbation and 10 mins of cool-down exercises.

Group C Task specific with perturbation

Specific yoga poses with perturbation OTHER

Group D training session consists of a 10-minute warm-up, 20 minutes of yoga exercises with perturbation, and a 10-minute cool-down

Group D Specific yoga Poses with Perturbation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 60
• Males and females with regular medical follow-up, physically autonomous but not doing regular physical activity.
• FRAT Score below 15
• Elders having difficulty in executive function (MMSE score more than 25¬).

You may not qualify if:

• Elderly people confined to bed, using wheelchairs, or unable to walk
• Elderly individuals with severe cognitive impairment, hemodynamic instability, or severe heart disease.
• Patients with uncontrolled hypertension, as verified by physicians.

Sponsors & Collaborators

• Shifa Tameer-e-Millat University: lead

Study Sites (1)

Shifa Tameer e Millat University

Islamabad, Federal, 44000, Pakistan

Location

Study Officials

• Saima Gul Associate Professor, PhD

  Shifa Tammer e Millat University, Islamabad, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: * Appropriate research strategy: Experimental study * Appropriate sampling method; non probability convenient sampling * Appropriate variable selected \& defined; yes * State study design; randomized trail

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: January 9, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)