Clinical trial NCT06875388: Task-Specific Training vs. Yoga (With and Without Perturbation) for Balance and Leg Strength in Older Adults
Official title: Effectiveness of Task-specific Training vs Different Yoga Poses With and Without Perturbation to Improve Reactive Balance and Overall Leg Strength in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Shifa Tameer-e-Millat University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Appropriate research strategy: Experimental study
* Appropriate sampling method; non probability convenient sampling
* Appropriate variable selected \& defined; yes
* State study design; randomized trail
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: Inclusion Criteria:

* 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¬).

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: Manual Release from Lean (MRFL) Test:
timeFrame: 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
measure: Mini Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: 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
measure: Manual Muscle Testing (MMT):
timeFrame: 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
measure: 30- secs sit to stand test
timeFrame: 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
measure: Mini Mental State Examination (MMSE)
timeFrame: 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:
measure: World Health Organization Quality of Life Brief Version ( WHOQOL-BREF )
timeFrame: 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
measure: The Barthel Scale/Index (BI)
timeFrame: 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
measure: Mini Stroop test
timeFrame: 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
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shifa Tameer e Millat University
state: Federal
Study officials:
affiliation: Shifa Tammer e Millat University, Islamabad, Pakistan
name: Saima Gul Associate Professor, PhD
role: PRINCIPAL_INVESTIGATOR
References: