- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07548684
Rehabilitation Interventions After Cardiac Surgery in Older Adults
Rehabilitation Interventions After Cardiac Surgery in Older Adults: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of foot massage and kinesio taping on functional performance and kinesiophobia in older adults following cardiac surgery. Early mobilization after cardiac surgery is essential for improving recovery outcomes; however, pain, fear of movement (kinesiophobia), and reduced functional capacity may delay rehabilitation in older patients.
Participants aged 65 years and older who have undergone cardiac surgery will be randomly assigned to either a foot massage group or a kinesio taping group. The foot massage group will receive daily bilateral foot massage for seven consecutive days, while the kinesio taping group will receive standardized kinesio taping applications to the foot and ankle region during the same period.
Functional performance, kinesiophobia, pain intensity, cognitive status, and delirium will be assessed using validated outcome measures, including the Timed Up and Go test, Tampa Scale for Kinesiophobia, Visual Analog Scale, Standardized Mini-Mental Test, and Nursing Delirium Screening Scale. Assessments will be conducted preoperatively and on the seventh postoperative day.
The study aims to determine whether non-pharmacological, easily applicable interventions such as foot massage and kinesio taping can enhance functional recovery, reduce fear of movement, and support early mobilization in older adults after cardiac surgery.
Study Overview
Status
Intervention / Treatment
Detailed Description
Cardiac surgery is associated with significant postoperative physical and psychological challenges, particularly in older adults. Age-related physiological changes, combined with the effects of major surgery, often result in decreased functional capacity, delayed mobilization, increased pain levels, and heightened fear of movement (kinesiophobia). Early mobilization is a key component of postoperative recovery; however, pain and psychological barriers may limit patients' willingness and ability to participate in rehabilitation processes.
Non-pharmacological interventions that are safe, simple, and easily applicable in clinical settings may play an important role in improving recovery outcomes. Foot massage is a widely used supportive intervention that can enhance circulation, stimulate sensory receptors, promote relaxation, and reduce pain perception. Similarly, kinesio taping is a non-invasive therapeutic approach that may improve proprioception, support joint stability, enhance circulation, and reduce pain through neuromuscular mechanisms.
Despite the potential benefits of these interventions, there is limited evidence regarding their effectiveness in older adults following cardiac surgery, particularly in relation to functional performance and kinesiophobia. Moreover, studies investigating the combined relationship between pain, functional mobility, and fear of movement in this population remain scarce.
The present study is designed as a randomized controlled trial to evaluate the effects of foot massage and kinesio taping on functional performance and kinesiophobia in older adults after cardiac surgery. Participants aged 65 years and older who have undergone cardiac surgery (e.g., coronary artery bypass grafting or valve surgery) and meet the inclusion criteria will be recruited from a tertiary hospital setting.
Eligible participants will be randomly assigned to one of two intervention groups: a foot massage group or a kinesio taping group. The foot massage group will receive standardized bilateral foot massage using the Swedish massage technique for 20 minutes daily over a 7-day postoperative period. The kinesio taping group will receive kinesio taping applications applied to the foot and ankle region according to standardized procedures, with applications repeated during the same 7-day period.
Outcome measures will include functional performance assessed by the Timed Up and Go (TUG) test, kinesiophobia assessed by the Tampa Scale for Kinesiophobia (TSK), pain intensity assessed by the Visual Analog Scale (VAS), cognitive status assessed by the Standardized Mini-Mental Test (SMMT), and delirium status assessed by the Nursing Delirium Screening Scale (Nu-DESC). Assessments will be conducted preoperatively and on the seventh postoperative day.
The primary objective of this study is to compare the effects of foot massage and kinesio taping on functional performance. Secondary objectives include evaluating their effects on kinesiophobia, pain, cognitive status, and delirium. It is hypothesized that both interventions will improve functional outcomes, with kinesio taping having a greater effect on reducing kinesiophobia and foot massage having a stronger effect on pain reduction.
The findings of this study are expected to contribute to the development of effective, low-cost, and easily implementable rehabilitation strategies that support early mobilization and improve postoperative recovery in older adults undergoing cardiac surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Asuman SALTAN
- Phone Number: 05554728513
- Email: fzt_asuman@yahoo.com.tr
Study Contact Backup
- Name: selda mert
- Phone Number: 0 541 691 56 75
- Email: sselda.mertt@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥65 years
- Undergoing cardiac surgery (e.g., coronary artery bypass grafting or valve surgery)
- Conscious and able to cooperate
- Able to provide informed consent
Exclusion Criteria:
- Presence of neurological disorders (e.g., stroke, Parkinson's disease)
- Lower extremity amputation or severe deformity
- Impaired skin integrity in the application area
- Contraindications to massage or kinesio taping
- Refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Foot Massage Group
Participants will receive bilateral foot massage using the Swedish massage technique for 20 minutes daily over a 7-day postoperative period.
|
A standardized Swedish massage technique will be applied to the plantar surface of both feet.
The intervention will include stroking and kneading techniques applied from the metatarsal heads to the heel and toes.
Each session will last 20 minutes (10 minutes per foot) and will be performed daily for 7 consecutive days by a trained healthcare professional.
|
|
Experimental: Kinesio Taping Group
Participants will receive standardized kinesio taping applied to the foot and ankle region twice during a 7-day postoperative period.
|
Kinesio tape (5 cm width) will be applied to the foot and ankle region using standardized techniques.
One strip will be applied around the ankle, and two strips will be applied to support the medial and lateral longitudinal arches of the foot.
The tape will be applied with 25-75% tension and will be administered by a certified physiotherapist.
Applications will be performed twice during a 7-day postoperative period and monitored regularly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go (TUG) Test
Time Frame: Preoperative baseline and postoperative day 7
|
Functional mobility will be assessed using the Timed Up and Go (TUG) test.
The time (in seconds) required for the participant to stand up from a seated position, walk 3 meters, turn around, walk back, and sit down will be recorded.
Lower scores indicate better functional performance.
|
Preoperative baseline and postoperative day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
Time Frame: Preoperative baseline and postoperative day 7
|
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK).
The scale consists of 17 items scored between 17 and 68, with higher scores indicating greater fear of movement.
|
Preoperative baseline and postoperative day 7
|
|
Pain Intensity
Time Frame: Preoperative baseline and postoperative day 7
|
Pain intensity will be evaluated using the Visual Analog Scale (VAS), where participants rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain).
|
Preoperative baseline and postoperative day 7
|
|
Cognitive Function
Time Frame: Preoperative baseline and postoperative day 7
|
Cognitive status will be assessed using the Standardized Mini-Mental Test (SMMT), which evaluates orientation, memory, attention, and language functions.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
|
Preoperative baseline and postoperative day 7
|
|
Delirium Status
Time Frame: Preoperative baseline and postoperative day 7
|
Delirium will be assessed using the Nursing Delirium Screening Scale (Nu-DESC), a 5-item observational tool with scores ranging from 0 to 10. Higher scores indicate increased likelihood of delirium.
|
Preoperative baseline and postoperative day 7
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Asuman SALTAN, University of Yalova
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS-FOOT-KT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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