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Not yet recruiting NCT07023328

BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD)

No phase Interventional Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A structured ball exercise program.
Who it may be relevant to
Registry conditions: Frailty. Basic parameters: 65 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD): A Pragmatic, Open-label, Randomized Controlled Trial.

Overview

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.

Interventions

  • Behavioral A structured ball exercise program
    Pre-frail older adults will undergo a structured ball exercise program

Primary outcome measures

  • 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.]
Secondary outcome measures (8)
  • Grip strength measurement [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 Five Times Sit to Stand Test (5TSTS) [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 4-m gait speed (4MGS) [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 Timed Up and Go test (TUG) [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.]
  • Lawton's Instrumental Activities of Daily Living (IADL) 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 Montreal Cognitive Assessment (MoCA) [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.]
  • Patient Health Questionnaire-4' (PHQ-4) [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.]
  • World Health Organization Well-Being Index (WHO-5) [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.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07023328 · BIO-2023-0255

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗