BalL Exercises tO Prevent FrAilty in OldeR ADults (LEOPARD)

ConditionFrailty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-75
SponsorAmerican University of Beirut Medical Center

About this 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 .

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Hospitalization within the past 3 months

Currently receiving oxygen therapy

Congestive heart failure (CHF) with an ejection fraction less than 25%

Severe aortic stenosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • A structured ball exercise program

    Behavioral

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Ball Exercise GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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 .

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 outcomes

1

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.

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.
2

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.

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.
3

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).

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.
4

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.

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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