Effects of BRACE Protocol on Fall Risk Among Elderly Population

NCT05340387 | Completed

• 1 other identifier: Ghulam Qadir
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the effects of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's exercises on fall risk among elderly population. And to determine the effects of BRACE and Otago's exercise on static and Dynamic balance in elderly population. the study will be randomized control trial including experimental and control group with estimated 17 individual in each group. Balance resistance aerobic resistance exercises will be performed by experimental group and Otago's protocol will be performed by control group.

Conditions

Fall Patients

Keywords

BRACE Protocol; Otago's Protocol; Fall Risk; Elderly Population

Outcome Measures

Primary Outcomes (5)

• Berg And Balance scale

  changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL \_\_/56

  12 weeks

• Time Up And Go

  changes from the baseline, Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: \<10 seconds = normal \<20 seconds = good mobility, can go out alone, mobile without a gait aid \<30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.

  12 week

• MOCA

  The Montreal Cognitive Assessment (MOCA) is a cognitive screening instrument developed to detect mild cognitive impairment (MCI). It is a simple 10 min paper and pencil test that assesses multiple cognitive domains including memory, language, executive functions, visuo-patial skills, calculation, abstraction, attention, concentration, and orientation. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal. In the initial study data, normal controls had an average score of 27.4. People with mild cognitive impairment (MCI) scored an average of 22.1. People with Alzheimer's disease had an average score of 16.2.

  12 weeks

• Gait dynamic index

  The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24.

  12 weeks

• Activity specific balance scale

  Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It's a 16-item questionnaire where patients' rate their confidence while doing activities. Scoring from 0-100 (0 is no confidence and 100 is full confidence).

  12 weeks

Study Arms (2)

Balance Resistance Aerobic Cognitive Exercises (BRACE)

EXPERIMENTAL

BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises.

Other: Balance Resistance Aerobic Cognitive exercises (BRACE)

Otago's Exercises

ACTIVE COMPARATOR

Otago's protocol is combination of warm up, strengthening, balance and flexibility exercises.

Other: Otago's Protocol

Interventions

Balance Resistance Aerobic Cognitive exercises (BRACE) OTHER

Study will be conducted after the approval of Ethical review board. The BRACE exercise training would be perform in 4 times a week for 12 weeks, lasting approximately 40-50 minutes each time. Week 1-3 : Balance: Romberg, tandom standing, single leg stance Resistance: chair rise Aerobic exercises: 6mint walk Cognitive: count reverse from 50 Week 4-6: Balance: Sit to stand, functional reach, Tug Test Resistance: stair climbing Aerobic Exercises: Marching in space Cognitive: Remember 5 words, spell backward, remember 5 animals Week 7-9: Balance: Perturbation, throwing a ball, kicking a ball Resistance: Floor transfer, squatting Aerobic Exercises: Cycling Cognitive: Count even number from 1-50, calculation, addition, subtraction, multiplication division Week 10-12: Balance: Combination of All Resistance: Combination of All Aerobic Exercises: 6 minutes' walk test, marching steps, cycling Cognitive: Combination of all

Balance Resistance Aerobic Cognitive Exercises (BRACE)

Otago's Protocol OTHER

Study will be conducted after the approval of Ethical review board. The Otago's exercise training would be perform in 4 times a week for 12 weeks, lasting approximately 40-50 minutes each time. WEEK 1-3: Warm up: March, head movement, neck movement, back extension, trunk movement, ankle movements Strength: Front knee strengthening, Back knee strengthening, Side hip strengthening, Calf raises, Toe raises (10 repetitions each) Balance: Knee bends, Backwards walking, Walking and turning around, Sideways walking, Tandem stance (heel toe stand), Tandem walk (heel toe walk), One leg stand, Heel walking, Toe walk, Heel toe walking backwards, Sit to stand, Stair walking. (10 repetitions each) Flexibility: calf stretch, back of thigh stretch Hold for 10 to 15 seconds and repeat on other leg. Walk: 5 or 10 minutes' walk This protocol will be followed for 12 weeks with increased repetitions after every 3 week.

Otago's Exercises

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• berg and balance 0-39
• MOCA score not less than 22

You may not qualify if:

• Severe cognitive impairment that prevented them from understanding instructions.
• Serious musculoskeletal, neurological and visual impairment that might affect measurement.
• Involvement in other exercise programs.
• Patients have vertebrobasilar insufficiency
• Atlanto-axial instability
• Osteoporosis
• Rheumatoid arthritis

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Helping Hand Institute of rehabilitation

Mānsehra, Khyber Pakhtunkhuwa, 2500, Pakistan

Location

Study Officials

• Nadia Azhar, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 22, 2022
• Study Start: April 5, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 30, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)