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

NCT ID: NCT06875388

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2025-07-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group A: task specific training

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.

Group Type: EXPERIMENTAL

Task specific Training

Intervention Type: 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 B specific Yoga poses

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 Type: EXPERIMENTAL

Specific Yoga Poses

Intervention Type: 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 C Task specific with perturbation

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.

Group Type: EXPERIMENTAL

Tasl specific Training with perturbation

Intervention Type: 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 D Specific yoga Poses with Perturbation

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 Type: EXPERIMENTAL

Specific yoga poses with perturbation

Intervention Type: 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

Interventions

Task specific Training

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.

Intervention Type: OTHER

Specific Yoga Poses

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.

Intervention Type: OTHER

Tasl specific Training with perturbation

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.

Intervention Type: OTHER

Specific yoga poses with perturbation

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shifa Tameer-e-Millat University

OTHER

Sponsor Role: lead

Responsible Party

Saima Gul

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saima Gul Associate Professor, PhD

Role: PRINCIPAL_INVESTIGATOR

Shifa Tammer e Millat University, Islamabad, Pakistan

Locations

Shifa Tameer e Millat University

Islamabad, Federal, Pakistan

Countries

Pakistan

Other Identifiers

IRB#545-24

Identifier Type: -

Identifier Source: org_study_id