BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD): A Pragmatic, Open-label, Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 80
- Primary Endpoint
- FRAIL scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes Assessor
Eligibility Criteria
- Ages
- 65 Years to 75 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
FRAIL scale
Time Frame: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
The FRAIL scale will be used to measure the participants' frailty status as the primary outcome. The FRAIL scale is an interview-based 5-item instrument that measures the level of frailty. It does not need physical performance measures. The items measure components of fatigue (self report), resistance (difficulty walking up 10 steps without resting), ambulation (difficulty walking 300 m), unintentional weight loss (\>5% in the past year), and illnesses (≥5 chronic conditions). The FRAIL scale scores range from 0-5 ((i.e., 1 point for each component; 0=best to 5=worst) and represents frail (3-5), prefrail (1-2), and robust (0) health states .
Secondary Outcomes
- Grip strength measurement(Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.)
- The Five Times Sit to Stand Test (5TSTS)(Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.)
- The 4-m gait speed (4MGS)(Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.)
- The Timed Up and Go test (TUG)(Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.)
- Lawton's Instrumental Activities of Daily Living (IADL) Scale(Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.)
- The Montreal Cognitive Assessment (MoCA)(Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.)
- Patient Health Questionnaire-4' (PHQ-4)(Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.)
- World Health Organization Well-Being Index (WHO-5)(Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.)