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

NCT ID: NCT04636645

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-19
• Study Completion Date: 2021-12-30

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?

Conditions

Old Age; Fall

Study Design

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

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Normal treadmill

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Anti-gravity treadmill with lower limb positive pressure

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Anti-gravity treadmill with without lower limb positive pressure

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Waqar Ahmed Awan, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Waqar Ahmed Awan

Role: CONTACT

waqar.ahmed@riphah.edu.pk

03324390125

Facility Contacts

Hina Shafi

Role: primary

hina.shafi@fui.edu.pk

03339802435

Other Identifiers

Riphah/RCRS/REC/0011961

Identifier Type: -

Identifier Source: org_study_id