Effects of Lower Limb Positive Pressure on the Balance of Community-dwelling Older Adults

With the onset of the sixth decade in life, degenerative processes affect the neuromuscular system in terms of losses in muscle strength (dynapenia) and muscle mass (sarcopenia). Neural (e.g., numerical loss of alpha motoneurons) and morphological factors. Borde et al. 123 number and size of particularly type-II muscle fibers), as well as their interaction, are responsible for age-related declines in muscle strength and mass. There is evidence that muscular weakness is highly associated with impaired mobility and an increased risk for falls. Moreover, lower extremity muscle weakness was identified as the dominant intrinsic fall-risk factor with a five-fold increase in the risk of falling. An anti-gravity treadmill allows users to walk or run in a reduced body weight environment. The user walks or runs on a treadmill belt surrounded by an enclosed, air-filled chamber. When air pressure increases, an upward force offloads the weight of the runner and decreases the percentage of body weight (BW%) experienced upon foot impact. So, a research question was developed in our mind after the literature review. Is there any effect of AGT training on fall risk of older adults?

Study Overview

• Status: Recruiting
• Conditions: Fall; Old Age
• Intervention / Treatment: Other: Normal treadmill; Other: Anti-gravity treadmill with lower limb positive pressure; Other: Anti-gravity treadmill with without lower limb positive pressure

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Waqar Ahmed Awan; Phone Number: 03324390125; Email: waqar.ahmed@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 44000
      • Recruiting
      • Fauji Foundation Hospital
      • Contact: Hina Shafi; Phone Number: 03339802435; Email: hina.shafi@fui.edu.pk
      • Principal Investigator: Hina Shafi, Phd*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Community-dwelling adults aged 55 years and above.
2. Berg balance score should be from 46 to 54.
3. Able to follow instructions in Urdu.
4. No neurological conditions, and no musculoskeletal injuries within the past year.
5. Both male and female.

Exclusion Criteria:

1. Pain with ambulation or dizziness when standing or walking.
2. Contraindications to treadmill walking and LBPP such as cardiovascular conditions.
3. Severe osteoporosis, fractures, when loading of the abdominal region, hip or pelvis is contraindicated (such as groin infections, skin graft in the groin region, gastrointestinal tubes, colostomy, compromised skin integrity), orthopedic conditions in the past year or neurological conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Normal Treadmill; After completion of the baseline evaluation, Group A participants will exercise for 25 minutes under low-load walking conditions three times a week for 8 consecutive weeks on the AGT treadmill at a set speed of 3.1 mph at a 0-degree incline. For each session, 20% support will be given to participants	Other: Normal treadmill; Participants will exercise for 25 minutes under low-load walking conditions three times a week for 8 consecutive weeks on the AGT treadmill at a set speed of 3.1 mph at 0-degree incline. For each session, 20% support will be given to participants.
EXPERIMENTAL: Anti-gravity treadmill with lower limb positive pressure; Group B participants will be exercised for 25 minutes under normal-load walking conditions three times a week for 8 consecutive weeks on the AGT treadmill at a set speed of 3.1 mph at a 0-degree incline. Participants will be blinded to the study groups.	Other: Anti-gravity treadmill with lower limb positive pressure; Participants will be exercised for 25 minutes under normal-load walking conditions three times a week for 8 consecutive weeks on the AGT treadmill at a set speed of 3.1 mph at 0-degree incline. Participants will be blinded to the study groups.
EXPERIMENTAL: Anti-gravity treadmill with without lower limb positive pressure; Group C participants will be exercised for 25 minutes three times a week for 8 consecutive weeks on the normal treadmill at a set speed of 3.1 mph at a 0-degree incline. Participants will be blinded to the study groups.	Other: Anti-gravity treadmill with without lower limb positive pressure; Participants will be exercised for 25 minutes three times a week for 8 consecutive weeks on the normal treadmill at a set speed of 3.1 mph at a 0-degree incline. Participants will be blinded to the study groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go test (TUG)	Test is also commonly used to evaluate fall risk.A faster time for completion of required task indicates a better ability to perform functional activities. The person sits up from the chair after instruction and walks at his normal pace for 3 meters, takes a turn and sits down after walking back towards the chair. The total duration required for this activity is measured using a stop watch.	12 week
Berg balance scale	Evaluation of functional balance was done using BBS which is valid and reliable tool for dynamic and static balance assessment. It consists of 14 Items and balance is assessed using an ordinal scale comprising 5 points that ranges from 0 to 4. High scores are indicative of superior balance where as low scores are suggestive of increased fall risk and poor balance.	12 week
Functional reach test	This test is used to assess stability level of patient. The assessment is carried out by calculating the maximum distance a person is able to reach forward in a fixed standing position. The assessment is carried out by calculating the maximum distance a person is able to reach forward in a fixed standing position. Lower distance of functional reach test indicated higher risk of fall and deteriorated balance and vice versa.	12 week
Fall risk score	FRS provide an objective assessment of static and dynamic balance and was assessed using dynamic posturo graphy system. High scores of FRS indicated higher risk of fall and deteriorated balance and vice versa.	12 week
Balance App	There are six different tasks that subject have perform with system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and close and standing on a compromised surface with eyes open and close. High scores indicated higher risk of fall and deteriorated balance and vice versa.	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Force Plate	Force plates is portable, non-invasive and quantitative instrument used to measure the ground reaction forces, variation in center of gravity and forces impact on foot. Postural sways will be calculated from force plate data. Randomness in data show increase risk of fall and poor balance.	12 week.

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2020
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: November 8, 2020
• First Submitted That Met QC Criteria: November 15, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Riphah/RCRS/REC/0011961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No