BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD)

American University of Beirut Medical Center

Status: Not yet enrolling

Conditions: Frailty

Treatments: Behavioral: A structured ball exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT07023328

BIO-2023-0255

Details and patient eligibility

About

This study aims to examine the effects of a multi-component intervention incorporating Swiss ball exercises and nutritional counseling on reducing frailty in a sample of pre-frail older adults in primary care. It also aims to assess its effects on physical performance, functional status, and cognitive and well-being measures.

Participants aged between 65 and 75 years will be randomly assigned to the intervention group and "usual care" group .

Over a 3-month period, the multi-component intervention will consist of Swiss ball exercises and nutritional counseling, whereas the "usual care" group will get verbal general health counseling on healthy eating and physical activity recommendations.

Outcome Assessors who are blinded to treatment allocation will evaluate primary and secondary outcomes at the end of the intervention (3 months), and after 6 months follow-up period.

Enrollment: 80 estimated patients

Sex: All

Ages: 65 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age between 65 and 75 years
• Pre-frail status according to the FRAIL Scale assessment
• Ability to rise from a chair without assistance
• Ability to perform the Apley scratch test
• Ability to bend forward without significant pain

Exclusion Criteria

• Hospitalization within the past 3 months
• Currently receiving oxygen therapy
• Congestive heart failure (CHF) with an ejection fraction less than 25%
• Severe aortic stenosis
• Uncontrolled paroxysmal vertigo
• Active neoplastic disease or terminal illness
• Severe cognitive impairment
• Neurological disorders (e.g., Parkinson's disease, multiple sclerosis)
• Bedridden status
• Major disability or mobility disorder
• Chest pain at rest, during activities, or with physical exertion
• History of loss of consciousness within the past 12 months
• Medical advice to avoid vigorous physical activity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Ball Exercise Group

Experimental group

Description:

Participants in this arm are pre-frail older adults who will undergo a structured ball exercise program

Treatment:

Behavioral: A structured ball exercise program

Usual Care Group

No Intervention group

Description:

Participants in this arm are pre-frail older adults who will usual care