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

R

Riphah International University

Status

Unknown

Conditions

Old Age
Fall

Treatments

Other: Normal treadmill
Other: Anti-gravity treadmill with without lower limb positive pressure
Other: Anti-gravity treadmill with lower limb positive pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT04636645
Riphah/RCRS/REC/0011961

Details and patient eligibility

About

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?

Enrollment

90 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Normal Treadmill
Active Comparator group
Description:
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
Treatment:
Other: Normal treadmill
Anti-gravity treadmill with lower limb positive pressure
Experimental group
Description:
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.
Treatment:
Other: Anti-gravity treadmill with lower limb positive pressure
Anti-gravity treadmill with without lower limb positive pressure
Experimental group
Description:
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.
Treatment:
Other: Anti-gravity treadmill with without lower limb positive pressure

Trial contacts and locations

1

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Central trial contact

Waqar Ahmed Awan

Data sourced from clinicaltrials.gov

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