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Effect of VIVIFRAIL exercises on multidimensional frailty and the consequences of knee osteoarthritis the community-dwelling elderly population: a randomized clinical trial study

Effect of VIVIFRAIL exercises on multidimensional frailty and the consequences of knee osteoarthritis the community-dwelling elderly population: a randomized clinical trial study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241210064008N1
Enrollment
140
Registered
2025-08-12
Start date
2025-09-11
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis.

Interventions

Intervention 1: Intervention group: An initial visit will be conducted with the participants in the intervention group, in which the participants' functional capacity status and risk of falling will b
Type B program is for people with disabilities, Type C1 program is for pre-disabled people who can walk unaided for 10 to 30 minutes, Type C2 program is for pre-disabled people who can walk unaided fo

Sponsors

Shahroud University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 60 years and older Ability to use a mobile phone, Knee osteoarthritis based on physician diagnosis and American College of Rheumatology criteria (based on American College of Rheumatology clinical criteria, patients who have knee pain on most days of the week and meet 3 of 6 criteria (age 50 years or older, stiffness less than 30 minutes per day, crepitus, bone tenderness, bone enlargement, absence of palpable heat) Obtaining a score higher than 5 for illiterate elderly and obtaining a score higher than 6 for literate elderly on the Short Portable Cognitive Status Questionnaire (SPMSQ) Presence of at least mild disability in one of the disability dimensions, based on the Comprehensive Disability Assessment Instrument Plus (CFAI-PLUS)

Exclusion criteria

Exclusion criteria: Gout Knee replacement surgery Chronic life-threatening diseases with a life expectancy of less than 3 months, Severe visual or hearing impairment, Patient participation in exercise programs or other research interventions, Uncontrolled hypertension or uncontrolled postural hypotension Acute myocardial infarction or unstable angina Uncontrolled cardiac arrhythmias Acute or severe heart failure Acute endocarditis or pericarditis Severe aortic aneurysm or stenosis Acute and severe respiratory failure Uncontrolled diabetes or hypoglycemia Acute thromboembolic diseases Fracture in the last month Hospitalization during the intervention period for any reason

Design outcomes

Primary

MeasureTime frame
Disability rates and consequences of knee osteoarthritis. Timepoint: Twelve weeks, an initial visit will be made with the intervention group, telephone calls will be made in the first week and then monthly throughout the intervention period. Method of measurement: For this purpose, an initial visit will be conducted with the intervention group, in which the participants' functional capacity status and risk of falling will be determined by performing the relevant tests specified in the VIVIFRAIL exercise program. Different functional capacity levels will be determined based on the scores obtained from the Short Physical Performance Battery (SPPB) or the 6-meter walk speed test (WS). To assess the risk of falling, 4 items will be assessed, including a history of 2 or more falls in the past year, decreased performance in the TUG test (20 seconds or more) and the 6-meter walk speed test (more than 7.5 seconds), and cognitive impairment. Demographic information form, Multidimensional Disability Inventory (CFAI-PLUS) and the Complementary and Alternative Medicine (CIMA) questionnaire will be used.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayeh Mobaraki

Shahroud University of Medical Sciences

somayemobaraki6@gmail.com+98 23 3239 5054

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026