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Impact of a Multicomponent Exercise Program on Physical Function and Quality of Life in Pre-frail and Frail Older Women

Impact of a Multicomponent Exercise Program on Physical Function and Quality of Life in Pre-frail and Frail Older Women: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001224415
Enrollment
70
Registered
2025-11-05
Start date
2025-12-01
Completion date
2026-02-02
Last updated
2025-11-10

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

Conditions

None listed

Brief summary

This study aims to examine whether a structured exercise program can improve physical abilities and overall quality of life in older women who are at risk of frailty or already frail. We hypothesize that participating in a multicomponent exercise program will lead to better balance, strength, mobility, and overall well-being compared to usual care.

Interventions

Arm 1 – Intervention Group: This intervention consists of a two-phase multicomponent exercise program Phase 1: Centre-based Multicomponent Exercise Program Duration & Frequency: 12 weeks 3 sessions per week Each session is 60 minutes Session Components: Warm-Up (10 minutes): Brisk walking for 5 minutes, static and dynamic stretching of the neck, shoulders, arms, hips, knees, and ankles Strength/Resistance Training (20 minutes): conducted in circuits, with each exercise performed for 3 sets of 7

Arm 1 – Intervention Group: This intervention consists of a two-phase multicomponent exercise program Phase 1: Centre-based Multicomponent Exercise Program Duration & Frequency: 12 weeks 3 sessions per week Each session is 60 minutes Session Components: Warm-Up (10 minutes): Brisk walking for 5 minutes, static and dynamic stretching of the neck, shoulders, arms, hips, knees, and ankles Strength/Resistance Training (20 minutes): conducted in circuits, with each exercise performed for 3 sets of 7–10 repetitions. The intensity progressed according to the Borg CR10 scale, starting at 3–4 and progressing to 5–7 over the program. Balance Training (10 minutes) such as sideways walking along a straight line, and heel-to-toe standing for 10 seconds. The progression of exercise is based on participant's ability (e.g., holding onto support vs. no support). Aerobic Training (10 minutes): Performed at intensity levels 3–4 on CR10 scale and progressed every 2 weeks. Cool-Down (10 minutes): Deep breathing and static stretching for neck, shoulders, back, hips, thighs, calves, and ankles Intervention Setting: Intervention will be delivered in-person by certified exercise specialists in a group sessions of 5–8 participants in a community center Adherence Monitoring: Participants’ adherence to the intervention will be monitored using session attendance checklists completed by the exercise supervisor at each session. Phase 2: Home-based Multicomponent Exercise Program (VIVIFRAIL©) After completion of the 12-week centre-based program; participants will be assessed using Short Physical Performance Battery (SPPB) and according to the results will be assigned to the proper VIVIFRAIL© programs as following: Passport B corresponds to Category B: For frail individuals (SPPB 4–6) Passport B+ corresponds to Category B: Frail with fall risk Passport C corresponds to Category C: Pre-frail individuals (SPPB 7–9) Passport C+ corresponds to Category C: Pre-frail with fall risk A comprehensive description of the Vivifrail program is available at [http://vivifrail.com/resources/] Duration of VIVIFRAIL© home program : 12 weeks Participants are expected to perform their home exercise 3 to 5 times per week Printed exercise booklets tailored to their classification will be given to each participant with daily exercise diary to record adherence 1. Functional Category: Pre-frail / Low Risk (Category A) • Examples of Exercises: o Sit-to-stand repetitions o Biceps curls with light weights o Calf raises o Tandem stance o Heel-to-toe walk o Walking 5–10 minutes o Marching in place • Intensity: Low to moderate, tailored to participant’s capacity (using Borg CR-10) • Frequency & Duration: 3–5 sessions per week, ~45 minutes per session • Adherence Monitoring: exercise log; weekly phone check-in by study staff 2. Functional Category: Frail (Category B) • Examples of Exercises: o Sit-to-stand (fewer repetitions) o Knee extensions with ankle weights o Seated arm raises o Single-leg stance o Side stepping o Walking along a line o Short bouts of walking (3–5 minutes) o Step-ups • Intensity: Low to moderate, adjusted individually based on participant’s ability (using Borg CR-10) • Frequency & Duration: 3–5 sessions per week, 45–60 minutes per session • Adherence Monitoring: exercise log; weekly phone check-in by study staff 3. Functional Category: Very Frail / High Risk (Category C) • Examples of Exercises: o Seated knee extensions o Seated biceps curls o Heel raises while holding a chair o Sit-to-stand with support o Mini squats holding a chair o Weight shifts while seated o Short walking with assistance o Marching in place (seated or standing with support) • Intensity: Low, according to participant’s ability (using Borg CR-10) • Frequency & Duration: 3 sessions per week, 30–45 minutes per session • Adherence Monitoring: exercise log; weekly phone check-in by study staff

Sponsors

Prince sattam bin Abdulaziz University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria will be: (1) Community-dwelling women aged 50 years or older (2) Fluent in spoken and written arabic (3) Able to walk 10 meters without assistance (4) Have not received any rehabilitation during the trial period (5) Have pre-frailty or frailty as defined by the frail scale

Exclusion criteria

The exclusion criteria will be: (1) diagnosed with significant neurological conditions, such as Parkinson’s disease or epilepsy (2) acute lower back or lower limb pain, or severe orthopaedic issues that may interfere with the resistance training (3) severe vision or hearing impairment that prevents normal communication (4) diagnosed with a major illness (e.g., cancer) or undergone major surgery in the past 6 months (5) acute stages of various diseases or severe organ failure, such as acute infections, gastrointestinal bleeding, heart failure, respiratory failure, renal failure, etc. (6) uncontrolled diabetes, hypertension, or heart disease (7) metal implants such as pacemakers or artificial joints (8) severe cognitive impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026