Clinical trial NCT07023328: BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD): A Pragmatic, Open-label, Randomized Controlled Trial.
Official title: BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD): A Pragmatic, Open-label, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Age: 65 to 75 years of age Frailty Status: Pre-frail 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 during the last 3 months. On oxygen therapy. Congestive heart failure (CHF) with reduced ejection fraction less than 25%. Severe aortic stenosis. Uncontrolled paroxysmal vertigo. Active neoplastic disease or terminal illness. Severe cognitive impairment. Other neurological disorders (e.g., Parkinson's disease, MS). Bedridden status. Major disability and mobility disorders. Chest pain at rest, during activities, or physical activity. Loss of consciousness in the past 12 months. Advised to avoid vigorous physical activity by a doctor.

Primary outcomes:
measure: FRAIL scale
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
Secondary outcomes:
measure: Grip strength measurement
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
measure: The Five Times Sit to Stand Test (5TSTS)
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
measure: The 4-m gait speed (4MGS)
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
measure: The Timed Up and Go test (TUG)
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
measure: Lawton's Instrumental Activities of Daily Living (IADL) Scale
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
measure: Patient Health Questionnaire-4' (PHQ-4)
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
measure: World Health Organization Well-Being Index (WHO-5)
timeFrame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
Other outcomes:
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