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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04636645
Collaborator
(none)
90
1
3
13.3
6.7

Study Details

Study Description

Brief Summary

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?

Condition or Disease Intervention/Treatment Phase
  • Other: Normal treadmill
  • Other: Anti-gravity treadmill with lower limb positive pressure
  • Other: Anti-gravity treadmill with without lower limb positive pressure
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Lower Limb Positive Pressure on the Balance of Community-dwelling Older Adults
Actual Study Start Date :
Nov 19, 2020
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Timed up and go test (TUG) [12 week]

    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.

  2. Berg balance scale [12 week]

    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.

  3. Functional reach test [12 week]

    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.

  4. Fall risk score [12 week]

    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.

  5. Balance App [12 week]

    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.

Secondary Outcome Measures

  1. Force Plate [12 week.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fauji Foundation Hospital Rawalpindi Punjab Pakistan 44000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Waqar Ahmed Awan, PhD, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT04636645
Other Study ID Numbers:
  • Riphah/RCRS/REC/0011961
First Posted:
Nov 19, 2020
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 12, 2021