Frailty(LEOPARD)NCT07023328
BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD)
A study testing A structured ball exercise program in people with Frailty, run by American University of Beirut Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Frailty
- What is being tested?
- A structured ball exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD): A Pragmatic, Open-label, Randomized Controlled Trial.
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 .
Read more
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.
- Conditions
- Frailty
- Being tested
- A structured ball exercise program
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A structured ball exercise programBehavioural
Pre-frail older adults will undergo a structured ball exercise program
| Study group | Role | What they receive |
|---|---|---|
| Ball Exercise Group | Experimental | Participants in this arm are pre-frail older adults who will undergo a structured ball exercise program Receives: Behavioral: A structured ball exercise program |
| Usual Care Group | No intervention | Participants in this arm are pre-frail older adults who will usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
FRAIL scale
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 .
Measured: 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 (8)
Grip strength measurement
Physical performance measures will be conducted. Upper muscle strength will be measured using the grip strength measurement. Maximum grip strength of the dominant hand (in kg) will be measured during vital signs measurements using a Jamar digital dynamometer grip. Grip strength in kilograms will be measured using a standardized protocol; participants will be seated with the ipsilateral shoulder adducted and neutrally rotated, the elbow flexed to 90 degrees, and the forearm and wrist neutrally positioned. The participants will be asked to perform three maximum force trials with their dominant hand interspersed by 1 minute and the highest measure observed will be observed.
Measured: 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)
Physical performance measures will be conducted. Lower limb strength will be measured using the Five Times Sit to Stand Test (5TSTS).Participants will be instructed to rise as quickly as possible from a seated position, with full body weight on the chair, to a standing posture, with their legs fully extended, while keeping their arms folded across their chest. The 5TSTS measures the time taken, in seconds, to complete five repeated chair stands. The test performance will be based on its duration; consequently, the shorter time taken by the patient, the better their functional condition would be.
Measured: 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)
To perform the test, a flat unobstructed course will be identified and 4 m marked out with tape. The participant will be positioned with the toes just touching the start line. The following standardized instructions will be given: "This is our walking course. I want you to walk to the other end of the course at your usual speed, just as if you were walking down the street to go to the shops. Walk all the way past the other end of the tape before you stop. Ready…begin". Timing with a stopwatch will be started when the participant begins to move, not on the command "begin". Timing will be stopped when the participant's first foot completely crosses the 4-m line. The walk test will be repeated without rest and the faster of the two times will be used to calculate the 4MGS, expressed in m·s-1. Participants will be allowed to use their normal walking aids (e.g. cane).
Measured: 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)
The participant will be asked to sit on a chair (chair height=45cm) with an upright posture, feet placed flat on the ground, and arms crossed on their chest. Next, participants will be instructed to rise from the chair, walk to, and around a cone (three meters) in front of them, walk back to the chair, and return to the starting position. Time will be recorded starting the moment the participant's back loses contact with the chair and concluded when the starting position is regained. A score of ≥ 14 seconds has been shown to indicate reduced mobility, impaired balance, and a high risk of falls.
Measured: 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
Functional status will be assess using the Lawton's Instrumental Activities of Daily Living (IADL) Scale). The Lawton IADL Scale takes approximately 10 to 15 minutes to administer. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning). For men, the areas of food preparation, housekeeping, and laundering will be excluded. Participants are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 to 5 for men.
Measured: 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)
Cognitive function will be measured using the Montreal Cognitive Assessment (MoCA). The MoCA test is conducted over 20 minutes to measure seven cognitive domains, including executive functions, naming, verbal memory registration and learning, attention, abstraction, delay recall memory, and orientation. MoCA scores range from 0 to 30, higher scores reflect good global cognitive function.
Measured: 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)
PHQ-4 will be used to screen for depression and anxiety. PHQ-4 is a 4-item inventory rated on a 4-point Likert-type scale with response options including the following: not at all (score = 0), several days (score = 1), more than half the days (score = 2), and nearly every day (score = 3). PHQ-4 scores will be computed by adding scores on individual items. PHQ-4 scores determine 'Severe' (score range 9-12), 'Moderate' (6-8), 'Mild' (3-5), and 'Normal' (0-2) risk of anxiety or depression. On each subscale, a score of 3 or greater is considered a risk for anxiety or depression.
Measured: 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)
The 5-item World Health Organization Well-Being Index (WHO-5) is a short questionnaire covering five positively worded items, related to positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things). Each of the five items in the WHO-Five is rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). The raw score ranges from 0 to 25, and the percentage final score (0-100%) can be obtained by multiplying the result by 4. A cutoff of <13 (or <50%) indicates poor psychological well-being.
Measured: Measurements will be assessed at baseline (before randomization) after 3 months at the end of the intervention, and after 6 months follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023328
- Sponsor's protocol ID
- BIO-2023-0255
- Acronym
- (LEOPARD)
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD): A Pragmatic, Open-label, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07023328
- Acronym / sponsor ID
- (LEOPARD) / BIO-2023-0255
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ball Exercise Group | Experimental | Behavioral: A structured ball exercise programParticipants in this arm are pre-frail older adults who will undergo a structured ball exercise program |
| Usual Care Group | No intervention | –Participants in this arm are pre-frail older adults who will usual care |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A structured ball exercise programPre-frail older adults will undergo a structured ball exercise program | Behavioural | Ball Exercise Group |
Primary outcome
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 .
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A structured ball exercise program in people with Frailty, run by American University of Beirut Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.