Task-Specific Training vs. Yoga (With and Without Perturb... | NCT06875388

NCT06875388

Status Module

Description Module

Detailed Description

Plan of Work: males and females above 60 as per eligibility criteria will be enrolled Baseline Assessment: all variables Manual release from leans for reactive Balance, Minbest test questionnaire, Manual Muscle testing, Stroop test, Barthel Index scale, 30 sec-sit to stand test, WHOQOL questionnaire will be measured at the baseline Randomization & Allocation: Eligible consenting subjects will be randomly allocated to all four groups Follow-up Assessment: All the outcome measures observed at baseline will be re-assessed after 3 months of intervention and then 1 month after stopping the intervention.

Statistical Analysis: Pre & post-analysis will be conducted.

study design: it will be an experimental study and non- probability-convenient sampling method will be used. data will be collected from the old homes of Islamabad/ Rawalpindi after seeking approval from the authorities. A randomized control trial will be carried out to enroll older male and female individuals into 4 separate groups with random allocation through the sealed envelope method. 50 individuals will be located in each group. After achieving informed consent from all the participants, a baseline assessment will be conducted. Baseline- and post-intervention assessments of the reactive balance and overall leg strength will be completed one week before the intervention and following the last training session, respectively. Both variables will be tested through reliable tests stated in the next session. Only participants fulfilling the inclusion criteria will be recruited in the study. Then a 12-week intervention of task-specific training vs yoga poses in combination with and without perturbation will be implemented on the study population, having 3 sessions per week and a post-intervention assessment will be conducted afterward

Participants including males and females above 60 will be recruited with no restriction for ethnicity or race. The participants from diverse socio-cultural backgrounds will be considered eligible if they meet the inclusion criteria. The study objective will be explained and participants will be invited to participate based on their free will.

Sampling size: The sample size was calculated using G power and taking the following parameters: Effect size f = 0.25, α err prob = 0.05, Power (1-β err prob) = 0.85, No of groups = 04 Total sample size = 204

Randomization: After assessing the eligibility the participants will be randomly allocated in a study groups through sealed envelop method (group A task-specific training, Group B yoga training, group C task-specific with perturbation, group D yoga with perturbation ). The randomization sequence will done through the sealed envelope method. 200 envelopes will be made ready with the name of each group on 50 envelopes. participants will be asked to pick one envelope. and then their group will be mentioned in the performa.

intervention: Group A will receive a basic protocol of 40 minutes involving 10 minutes warm up 10 10 mins of task-specific training 10 mins of leg strength exercises and 10 mins of cool-down exercises. 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 C will be 40 minutes involving 10 minutes of warm-up 10 mins of task-specific training involving perturbation 10 mins of leg strength exercises involving perturbation and 10 mins of cool-down exercises. Group D training session consists of a 10-minute warm-up, 20 minutes of yoga exercises with perturbation, and a 10-minute cool-down

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Measure	Description	Time Frame
World Health Organization Quality of Life Brief Version ( WHOQOL-BREF )	For assessing the quality of life: A shorter, 26-item version of the original 100-item WHOQOL questionnaire. It assesses four domains of quality of life: physical health, psychological health, social relationships, and environment. It is a self-report questionnaire, meaning individuals answer the questions themselves. Each of the 26 items in the WHOQOL-BREF is scored on a 5-level scale(e.g., 1- 5), allowing for the calculation of domain-specific and overall quality-of-life scores. Higher scores generally indicate a better quality of life.

Eligibility Module